0A4F4F9BD490A749D5437F821CF06DF1
21 CFR 807
https://www.govinfo.gov/content/pkg/CFR-2012-title21-vol8/pdf/CFR-2012-title21-vol8-part807.pdf
http://leaux.net/URLS/ConvertAPI Text Files/8779B68FFA7E06D52D96E72A472DF80C.en.txt
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| Indicators in focus are typically shown highlighted in yellow; |
Peer Indicators (that share the same Vulnerability association) are shown highlighted in pink; |
"Outside" Indicators (those that do NOT share the same Vulnerability association) are shown highlighted in green; |
Trigger Words/Phrases are shown highlighted in gray. |
Link to Orphaned Trigger Words (Appendix (Indicator List, Indicator Peers, Trigger Words, Type/Vulnerability/Indicator Overlay)
Applicable Type / Vulnerability / Indicator Overlay for this Input
Political / political affiliation
Searching for indicator party:
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p.000063: May 28, 1976, and that is classified into class III under section 513(f) of the act: Provided, That the de-
p.000063: vice is intended solely for investiga- tional use, and under section 501(f)(2)(A) of
p.000063: the act the device is not
p.000063:
p.000063:
p.000063:
p.000063:
p.000063:
p.000063:
p.000063:
p.000063:
p.000063: § 807.3
p.000063: required to have an approved pre- market approval application as pro- vided in section 515 of
p.000063: the act; or
p.000063: (4) For foreign establishments, the distribution of any device that is nei- ther imported nor offered
p.000063: for import into the United States.
p.000063: (c) Establishment means a place of business under one management at one general physical location at
p.000063: which a device is manufactured, assembled, or otherwise processed.
p.000063: (d) Manufacture, preparation, propaga- tion, compounding, assembly, or proc- essing of a device means
p.000063: the making by chemical, physical, biological, or other procedures of any article that meets the definition
p.000063: of device in section 201(h) of the act. These terms include the following activities:
p.000063: (1) Repackaging or otherwise chang- ing the container, wrapper, or labeling of any device package in
p.000063: furtherance of the distribution of the device from the original place of manufacture to the person who makes
p.000063: final delivery or sale to the ultimate consumer;
p.000063: (2) Initial importation of devices manufactured in foreign establish- ments; or
p.000063: (3) Initiation of specifications for de- vices that are manufactured by a sec- ond party for subsequent
p.000063: commercial distribution by the person initiating specifications.
p.000063: (e) Official correspondent means the person designated by the owner or op- erator of an establishment
p.000063: as respon- sible for the following:
p.000063: (1) The annual registration of the es- tablishment;
p.000063: (2) Contact with the Food and Drug Administration for device listing;
p.000063: (3) Maintenance and submission of a current list of officers and directors to the Food and Drug
p.000063: Administration upon the request of the Commissioner;
p.000063: (4) The receipt of pertinent cor- respondence from the Food and Drug Administration directed to
p.000063: and involv- ing the owner or operator and/or any of the firm’s establishments; and
p.000063: (5) The annual certification of med- ical device reports required by § 804.30 of this chapter or
p.000063: forwarding the cer- tification form to the person des- ignated by the firm as responsible for
p.000063: the certification.
p.000063:
p.000064: 64
p.000064: 21 CFR Ch. I (4–1–12 Edition)
p.000064: (f) O ner or operator means the cor- poration, subsidiary, affiliated com- pany, partnership, or
p.000064: proprietor di- rectly responsible for the activities of the registering establishment.
p.000064: (g) Initial importer means any im- porter who furthers the marketing of a device from a foreign
p.000064: manufacturer to the person who makes the final deliv- ery or sale of the device to the ulti- mate
...
p.000065:
p.000065: Subpart B—Procedures for Device Establishments
p.000065: § 807.20 Who must register and submit a device list?
p.000065: (a) An owner or operator of an estab- lishment not exempt under section 510(g) of the act or subpart D
p.000065: of this part who is engaged in the manufac- ture, preparation, propagation, compounding,
p.000065: assembly, or processing of a device intended for human use shall register and submit listing infor-
p.000065: mation for those devices in commercial distribution, except that registration and listing information may
p.000065: be sub- mitted by the parent, subsidiary, or af- filiate company for all the domestic or foreign establishments
p.000065: under the con- trol of one of these organizations when operations are conducted at more than one
p.000065: establishment and there exists joint ownership and control among all the establishments. The term
p.000065: ‘‘device’’ includes all in vitro diagnostic prod- ucts and in vitro diagnostic biological products not
p.000065: subject to licensing under section 351 of the Public Health Service Act. An owner or operator of an estab-
p.000065: lishment located in any State as de- fined in section 201(a)(1) of the act shall register its name, places of
p.000065: business, and all establishments and list the de- vices whether or not the output of the establishments
p.000065: or any particular de- vice so listed enters interstate com- merce. The registration and listing
p.000065: re- quirements shall pertain to any person who:
p.000065: (1) Initiates or develops specifica- tions for a device that is to be manu- factured by a second party
p.000065: for commer- cial distribution by the person initi- ating specifications;
p.000065:
p.000065:
p.000065:
p.000065:
p.000065:
p.000065:
p.000065:
p.000065:
p.000065: § 807.21
p.000065: (2) Manufactures for commercial dis- tribution a device either for itself or for another person. However,
p.000065: a person who only manufactures devices accord- ing to another person’s specifications, for commercial distribution
p.000065: by the per- son initiating specifications, is not re- quired to list those devices.
p.000065: (3) Repackages or relabels a device;
p.000065: (4) Acts as an initial importer; or
p.000065: (5) Manufactures components or ac- cessories which are ready to be used for any intended health-related
p.000065: purpose and are packaged or labeled for com- mercial distribution for such health-re- lated purpose, e.g., blood
p.000065: filters, hemo- dialysis tubing, or devices which of ne- cessity must be further processed by a licensed
p.000065: practitioner or other qualified person to meet the needs of a par- ticular patient, e.g., a
p.000065: manufacturer of ophthalmic lens blanks.
p.000065: (b) No registration or listing fee is re- quired. Registration or listing does not constitute an admission or
p.000065: agreement or determination that a product is a
p.000065: 21 CFR Ch. I (4–1–12 Edition)
p.000065: ditional listing information require- ments of § 807.31 remain applicable.
p.000065: [42 FR 42526, Aug. 23, 1977, as amended at 43
p.000065: FR 37997, Aug. 25, 1978; 58 FR 46522, Sept. 1,
p.000065: 1993; 60 FR 63606, Dec. 11, 1995; 63 FR 51826,
p.000065: Sept. 29, 1998; 66 FR 5466, Jan. 19, 2001; 66 FR
p.000065: 59160, Nov. 27, 2001]
p.000065:
p.000065: § 807.21 Times for establishment reg- istration and device listing.
p.000065: (a) An owner or operator of an estab- lishment who has not previously en- tered into an operation defined
p.000065: in
p.000065: § 807.20 shall register within 30 days after entering into such an operation and submit device
p.000065: listing information at that time. An owner or operator of an establishment shall update its reg- istration
p.000065: information annually within
p.000065: 30 days after receiving registration forms from FDA. FDA will mail form FDA-2891a to the owners or
p.000065: operators of registered establishments according to a schedule based on the first letter of the name of
p.000065: the owner or operator. The schedule is as follows:
p.000065:
p.000065: device within the meaning of section
p.000065: 201(h) of the act.
p.000065: (c) Registration and listing require- ments shall not pertain to any person who:
p.000065: (1) Manufacturers devices for another
p.000065: First letter of owner or oper- ator name
p.000065:
p.000065: A, B, C, D, E ..........................
p.000065: F, G, H, I, J, K, L, M ..............
p.000065: N, O, P, Q, R .........................
p.000065: S, T, U, V, W, X, Y, Z ...........
p.000065:
p.000065: Date FDA will mail forms
p.000065:
p.000065: March. June. August. November.
p.000065:
p.000065: party who both initiated the specifica- tions and commercially distributes the device;
p.000065: (2) Sterilizes devices on a contract basis for other registered facilities who commercially distribute the
p.000065: devices.
p.000065: (3) Acts as a wholesale distributor, as defined in § 807.3(s), and who does not manufacture, repackage,
p.000065: process, or relabel a device.
p.000065: (d) Owners and operators of establish- ments or persons engaged in the recov- ery, screening, testing,
p.000065: processing, storage, or distribution of human cells, tissues, and cellular and tissue-based products, as defined in
p.000065: § 1271.3(d) of this chapter, that are regulated under the Federal Food, Drug, and Cosmetic Act must
p.000065: register and list those human cells, tissues, and cellular and tissue- based products with the Center for
p.000065: Bio- logics Evaluation and Research on Form FDA 3356 following the proce- dures set out in
p.000065: subpart B of part 1271 of this chapter, instead of the proce- dures for registration and listing con-
p.000065: tained in this part, except that the ad-
p.000066: 66
p.000066: (b) Owners or operators of all reg- istered establishments shall update their device listing
p.000066: information every June and December or, at their discre- tion, at the time the change occurs.
p.000066: [58 FR 46522, Sept. 1, 1993]
p.000066:
p.000066: § 807.22 How and where to register es- tablishments and list devices.
p.000066: (a) The first registration of a device establishment shall be on Form FDA– 2891 (Initial Registration of
p.000066: Device Es- tablishment). Forms are available upon request from the Food and Drug Ad- ministration, Center
...
Political / stateless persons
Searching for indicator nation:
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p.000069: in more than one establishment provided there exists joint ownership and con- trol among all the
p.000069: establishments maintaining the historical file. If no joint ownership and control exists, the registered
p.000069: establishment must provide the Food and Drug Administration with a letter authorizing the establish- ment
p.000069: outside its control to maintain the historical file.
p.000069: (3) A copy of the certification and
p.000069: disclosure statements as required by part 54 of this chapter shall be retained and physically located at the
p.000069: establish- ment maintaining the historical file.
p.000069: (e) Each owner or operator shall be prepared to submit to the Food and Drug Administration, only
p.000069: upon spe- cific request, the following informa- tion:
p.000069: (1) For a device subject to section 514 or 515 of the act that is not a restricted
p.000069:
p.000069:
p.000069:
p.000069:
p.000069:
p.000069:
p.000069:
p.000069:
p.000069: § 807.35
p.000069: device, a copy of all labeling for the de- vice.
p.000069: (2) For a device that is a restricted device, a copy of all labeling for the de- vice, a representative
p.000069: sampling of ad- vertisements for the device, and for good cause, a copy of all advertise- ments
p.000069: for a particular device. A re- quest for all advertisements will, where feasible, be accompanied by an
p.000069: expla- nation of the basis for such request.
p.000069: (3) For a device that is neither a re- stricted device, nor subject to section 514 of 515 of the act, the
p.000069: label and pack- age insert for the device and a rep- resentative sampling of any other la- beling
p.000069: for the device.
p.000069: (4) For a particular device, a state- ment of the basis upon which the reg- istrant has determined that
p.000069: the device is not subject to section 514 or 515 of the act.
p.000069: (5) For a particular device, a state- ment of the basis upon which the reg- istrant has determined
p.000069: the device is not a restricted device.
p.000069: (6) For a particular device, a state- ment of the basis for determining that the product is a device
p.000069: rather than a drug.
p.000069: (7) For a device that the owner or op- erator has manufactured for distribu- tion under a label other than
p.000069: its own, the names of all distributors for whom it has been manufactured.
p.000069: [43 FR 37999, Aug. 25, 1978, as amended at 51
p.000069: FR 33033, Sept. 18, 1986; 63 FR 5253, Feb. 2,
p.000069: 1998]
p.000069: § 807.35 Notification of registrant.
p.000069: (a) The Commissioner will provide to the official correspondent, at the ad- dress listed on the form, a
p.000069: validated copy of Form FDA–2891 or Form FDA– 2891(a) (whichever is applicable) as evi- dence of registration. A
p.000069: permanent reg- istration number will be assigned to each device establishment registered in accordance with
p.000069: these regulations.
p.000069: (b) Owners and operators of device es-
...
Health / Drug Usage
Searching for indicator drug:
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p.000063:
p.000063:
p.000063:
p.000063:
p.000063:
p.000063:
p.000063:
p.000063:
p.000063:
p.000063:
p.000063:
p.000063:
p.000063:
p.000063: Food and Drug Administration, HHS § 807.3
p.000063:
p.000063:
p.000063: in accordance with part 20 of this chap- ter.
p.000063: (b) Before public disclosure of a re- port, FDA will delete from the report:
p.000063: (1) Any information that constitutes trade secret or confidential commer- cial or financial
p.000063: information under
p.000063: § 20.61 of this chapter; and
p.000063: (2) Any personnel, medical, or similar information, including the serial num- bers of implanted devices, which
p.000063: would constitute a clearly unwarranted inva- sion of personal privacy under § 20.63 of this chapter or 5 U.S.C.
p.000063: 552(b)(6); pro- vided, that except for the information under § 20.61 of this chapter or 5 U.S.C.
p.000063: 552(b)(4), FDA will disclose to a patient who requests a report all the informa- tion in the report
p.000063: concerning that pa- tient.
p.000063:
p.000063: PART 807—ESTABLISHMENT REG- ISTRATION AND DEVICE LISTING FOR MANUFACTURERS AND INI- TIAL IMPORTERS OF
p.000063: DEVICES
p.000063: Subpart A—General Provisions
p.000063: Sec.
p.000063: 807.3 Definitions.
p.000063:
p.000063: Subpart B—Procedures for Device Establishments
p.000063: 807.20 Who must register and submit a de- vice list?
p.000063: 807.21 Times for establishment registration and device listing.
p.000063: 807.22 How and where to register establish- ments and list devices.
p.000063: 807.25 Information required or requested for establishment registration and device listing.
p.000063: 807.26 Amendments to establishment reg- istration.
p.000063: 807.30 Updating device listing information.
p.000063: 807.31 Additional listing information.
p.000063: 807.35 Notification of registrant.
p.000063: 807.37 Inspection of establishment registra- tion and device listings.
p.000063: 807.39 Misbranding by reference to estab- lishment registration or to registration number.
p.000063:
p.000063: Subpart C—Registration Procedures for Foreign Device Establishments
p.000063: 807.40 Establishment registration and de- vice listing for foreign establishments importing or
p.000063: offering for import devices into the United States.
p.000063:
p.000063: 63
p.000063: Subpart D—Exemptions
p.000063: 807.65 Exemptions for device establish- ments.
p.000063:
p.000063: Subpart E—Premarket Notification Procedures
p.000063: 807.81 When a premarket notification sub- mission is required.
p.000063: 807.85 Exemption from premarket notifica- tion.
p.000063: 807.87 Information required in a premarket notification submission.
p.000063: 807.90 Format of a premarket notification submission.
p.000063: 807.92 Content and format of a 510(k) sum- mary.
p.000063: 807.93 Content and format of a 510(k) state- ment.
p.000063: 807.94 Format of class III certification.
p.000063: 807.95 Confidentiality of information.
p.000063: 807.97 Misbranding by reference to pre- market notification.
p.000063: 807.100 FDA action on a premarket notifica- tion.
p.000063: AUTHORITY: 21 U.S.C. 321, 331, 351, 352, 360,
p.000063: 360c, 360e, 360i, 360j, 371, 374, 381, 393; 42 U.S.C.
p.000063: 264, 271.
p.000063: SOURCE: 42 FR 42526, Aug. 23, 1977, unless
p.000063: otherwise noted.
p.000063:
p.000063: Subpart A—General Provisions
p.000063: § 807.3 Definitions.
p.000063: (a) Act means the Federal Food, Drug, and Cosmetic Act.
p.000063: (b) Commercial distribution means any distribution of a device intended for human use which is held
p.000063: or offered for sale but does not include the following:
p.000063: (1) Internal or interplant transfer of a device between establishments within the same parent, subsidiary,
p.000063: and/or af- filiate company;
p.000063: (2) Any distribution of a device in- tended for human use which has in ef- fect an approved exemption
p.000063: for inves- tigational use under section 520(g) of the act and part 812 of this chapter;
p.000063: (3) Any distribution of a device, be- fore the effective date of part 812 of this chapter, that was
p.000063: not introduced or delivered for introduction into inter- state commerce for commercial dis- tribution before
p.000063: May 28, 1976, and that is classified into class III under section 513(f) of the act: Provided, That the de-
p.000063: vice is intended solely for investiga- tional use, and under section 501(f)(2)(A) of
p.000063: the act the device is not
p.000063:
p.000063:
p.000063:
p.000063:
p.000063:
p.000063:
p.000063:
p.000063:
p.000063: § 807.3
p.000063: required to have an approved pre- market approval application as pro- vided in section 515 of
p.000063: the act; or
p.000063: (4) For foreign establishments, the distribution of any device that is nei- ther imported nor offered
p.000063: for import into the United States.
p.000063: (c) Establishment means a place of business under one management at one general physical location at
p.000063: which a device is manufactured, assembled, or otherwise processed.
p.000063: (d) Manufacture, preparation, propaga- tion, compounding, assembly, or proc- essing of a device means
p.000063: the making by chemical, physical, biological, or other procedures of any article that meets the definition
p.000063: of device in section 201(h) of the act. These terms include the following activities:
p.000063: (1) Repackaging or otherwise chang- ing the container, wrapper, or labeling of any device package in
p.000063: furtherance of the distribution of the device from the original place of manufacture to the person who makes
p.000063: final delivery or sale to the ultimate consumer;
p.000063: (2) Initial importation of devices manufactured in foreign establish- ments; or
p.000063: (3) Initiation of specifications for de- vices that are manufactured by a sec- ond party for subsequent
p.000063: commercial distribution by the person initiating specifications.
p.000063: (e) Official correspondent means the person designated by the owner or op- erator of an establishment
p.000063: as respon- sible for the following:
p.000063: (1) The annual registration of the es- tablishment;
p.000063: (2) Contact with the Food and Drug Administration for device listing;
p.000063: (3) Maintenance and submission of a current list of officers and directors to the Food and Drug
p.000063: Administration upon the request of the Commissioner;
p.000063: (4) The receipt of pertinent cor- respondence from the Food and Drug Administration directed to
p.000063: and involv- ing the owner or operator and/or any of the firm’s establishments; and
p.000063: (5) The annual certification of med- ical device reports required by § 804.30 of this chapter or
p.000063: forwarding the cer- tification form to the person des- ignated by the firm as responsible for
p.000063: the certification.
p.000063:
p.000064: 64
p.000064: 21 CFR Ch. I (4–1–12 Edition)
p.000064: (f) O ner or operator means the cor- poration, subsidiary, affiliated com- pany, partnership, or
p.000064: proprietor di- rectly responsible for the activities of the registering establishment.
p.000064: (g) Initial importer means any im- porter who furthers the marketing of a device from a foreign
p.000064: manufacturer to the person who makes the final deliv- ery or sale of the device to the ulti- mate
p.000064: consumer or user, but does not repackage, or otherwise change the container, wrapper, or labeling of
p.000064: the device or device package.
p.000064: (h) Any term defined in section 201 of the act shall have that meaning.
p.000064: (i) Restricted device means a device for which the Commissioner, by regulation under § 801.109 of this chapter or
p.000064: other- wise under section 520(e) of the act, has restricted sale, distribution, or use only upon the written
p.000064: or oral author- ization of a practitioner licensed by law to administer or use the device or upon
p.000064: such other conditions as the Com- missioner may prescribe.
p.000064: (j) Classification name means the term used by the Food and Drug Administra- tion and its classification panels to de-
p.000064: scribe a device or class of devices for purposes of classifying devices under section 513 of the act.
p.000064: (k) Representative sampling of adver- tisements means typical advertising ma- terial that gives the
p.000064: promotional claims made for the device.
p.000064: (l) Representative sampling of any other labeling means typical labeling mate- rial (excluding labels and
p.000064: package in- serts) that gives the promotional claims made for the device.
p.000064: (m) Material change includes any change or modification in the labeling or advertisements that
p.000064: affects the identity or safety and effectiveness of the device. These changes may include, but are not
p.000064: limited to, changes in the common or usual or proprietary name, declared ingredients or components, in- tended
p.000064: use, contraindications, warn- ings, or instructions for use. Changes that are not material may
p.000064: include graphic layouts, grammar, or correc- tion of typographical errors which do not change the content of
p.000064: the labeling, changes in lot number, and, for devices where the biological activity or known
p.000064:
p.000064:
p.000064:
p.000064:
p.000064:
p.000064:
p.000064:
p.000064: Food and Drug Administration, HHS § 807.20
p.000064:
p.000064:
p.000064: composition differs with each lot pro- duced, the labeling containing the ac- tual values for each lot.
p.000064: (n) 510(k) summary (summary of any information respecting safety and ef- fectiveness) means a summary,
p.000064: sub- mitted under section 513(i) of the act, of the safety and effectiveness informa- tion contained in a
p.000064: premarket notifica- tion submission upon which a deter- mination of substantial equivalence can be
p.000064: based. Safety and effectiveness information refers to safety and effec- tiveness data and information
p.000064: sup- porting a finding of substantial equiva- lence, including all adverse safety and effectiveness information.
p.000064: (o) 510(k) statement means a state- ment, made under section 513(i) of the act, asserting that all
p.000064: information in a premarket notification submission re- garding safety and effectiveness will be made available
p.000064: within 30 days of re- quest by any person if the device de- scribed in the premarket notification
p.000064: submission is determined to be sub- stantially equivalent. The information to be made available will be a
p.000064: duplicate of the premarket notification submis- sion, including any adverse safety and effectiveness
p.000064: information, but exclud- ing all patient identifiers, and trade se- cret or confidential commercial infor-
p.000064: mation, as defined in § 20.61 of this chapter.
p.000064: (p) Class III certification means a cer- tification that the submitter of the 510(k) has
p.000064: conducted a reasonable search of all known information about the class III device and other similar,
...
p.000065: information annually within
p.000065: 30 days after receiving registration forms from FDA. FDA will mail form FDA-2891a to the owners or
p.000065: operators of registered establishments according to a schedule based on the first letter of the name of
p.000065: the owner or operator. The schedule is as follows:
p.000065:
p.000065: device within the meaning of section
p.000065: 201(h) of the act.
p.000065: (c) Registration and listing require- ments shall not pertain to any person who:
p.000065: (1) Manufacturers devices for another
p.000065: First letter of owner or oper- ator name
p.000065:
p.000065: A, B, C, D, E ..........................
p.000065: F, G, H, I, J, K, L, M ..............
p.000065: N, O, P, Q, R .........................
p.000065: S, T, U, V, W, X, Y, Z ...........
p.000065:
p.000065: Date FDA will mail forms
p.000065:
p.000065: March. June. August. November.
p.000065:
p.000065: party who both initiated the specifica- tions and commercially distributes the device;
p.000065: (2) Sterilizes devices on a contract basis for other registered facilities who commercially distribute the
p.000065: devices.
p.000065: (3) Acts as a wholesale distributor, as defined in § 807.3(s), and who does not manufacture, repackage,
p.000065: process, or relabel a device.
p.000065: (d) Owners and operators of establish- ments or persons engaged in the recov- ery, screening, testing,
p.000065: processing, storage, or distribution of human cells, tissues, and cellular and tissue-based products, as defined in
p.000065: § 1271.3(d) of this chapter, that are regulated under the Federal Food, Drug, and Cosmetic Act must
p.000065: register and list those human cells, tissues, and cellular and tissue- based products with the Center for
p.000065: Bio- logics Evaluation and Research on Form FDA 3356 following the proce- dures set out in
p.000065: subpart B of part 1271 of this chapter, instead of the proce- dures for registration and listing con-
p.000065: tained in this part, except that the ad-
p.000066: 66
p.000066: (b) Owners or operators of all reg- istered establishments shall update their device listing
p.000066: information every June and December or, at their discre- tion, at the time the change occurs.
p.000066: [58 FR 46522, Sept. 1, 1993]
p.000066:
p.000066: § 807.22 How and where to register es- tablishments and list devices.
p.000066: (a) The first registration of a device establishment shall be on Form FDA– 2891 (Initial Registration of
p.000066: Device Es- tablishment). Forms are available upon request from the Food and Drug Ad- ministration, Center
p.000066: for Devices and Radiological Health, Office of Compli- ance, 10903 New Hampshire Ave., Bldg. 66, rm.
p.000066: 3521, Silver Spring, MD 20993– 0002, or from Food and Drug Adminis- tration district offices. Subsequent
p.000066: an- nual registration shall be accomplished on Form FDA–2891a (Annual Registra- tion of Device Establishment),
p.000066: which will be furnished by FDA to establish- ments whose registration for that year was validated under
p.000066: § 807.35(a). The
p.000066:
p.000066:
p.000066:
p.000066:
p.000066:
p.000066:
p.000066:
p.000066: Food and Drug Administration, HHS § 807.25
p.000066:
p.000066:
p.000066: forms will be mailed to the owner or operators of all establishments by the official correspondent in
p.000066: accordance with the schedule as described in
p.000066: § 807.21(a). The completed form shall be mailed to the address designated in this paragraph 30
p.000066: days after receipt from FDA.
p.000066: (b) The initial listing of devices and subsequent June and December updatings shall be on
p.000066: form FDA–2892 (Medical Device Listing). Forms are obtainable upon request as described in paragraph (a) of
p.000066: this section. A sepa- rate form FDA–2892 shall be submitted for each device or device class listed with
p.000066: the Food and Drug Administra- tion. Devices having variations in physical characteristics such as
p.000066: size, package, shape, color, or composition should be considered to be one device: Provided, The
p.000066: variation does not change the function or intended use of the device. In lieu of form FDA–2892,
p.000066: tapes for computer input or hard copy computer output may by submitted if equivalent in all elements of
p.000066: informa- tion as specified in form FDA–2892. All formats proposed for use in lieu of form FDA–2892 require
p.000066: initial review and ap- proval by the Food and Drug Adminis- tration.’’
p.000066: (c) The listing obligations of the ini- tial importer are satisfied as follows:
p.000066: (1) The initial importer is not re- quired to submit a form FDA-2892 for those devices for which such
p.000066: initial im- porter did not initiate or develop the specifications for the device or repack- age or relabel the
p.000066: device. However, the initial importer shall submit, for each device, the name and address of the
p.000066: manufacturer. Initial importers shall also be prepared to submit, when re- quested by FDA, the proprietary
p.000066: name, if any, and the common or usual name of each device for which they are the initial importers; and
p.000066: (2) The initial importer shall update the information required by paragraphs (c)(1) of this section at the
p.000066: intervals specified in § 807.30.
p.000066: [43 FR 37997, Aug. 25, 1978, as amended at 58
p.000066: FR 46522, Sept. 1, 1993; 60 FR 63606, Dec. 11,
p.000066: 1995; 63 FR 51826, Sept. 29, 1998; 69 FR 11311,
p.000066: Mar. 10, 2004; 69 FR 18473, Apr. 8, 2004; 69 FR
p.000066: 25489, May 7, 2004; 75 FR 20914, Apr. 22, 2010]
p.000066:
p.000067: 67
p.000067:
p.000067: § 807.25 Information required or re- quested for establishment registra- tion and device listing.
p.000067: (a) Form FDA–2891 and Form FDA– 2891(a) are the approved forms for ini- tially providing the
p.000067: information re- quired by the act and for providing an- nual registration, respectively. The re- quired
p.000067: information includes the name and street address of the device estab- lishment, including post office code,
p.000067: all trade names used by the establishment, and the business trading name of the owner or operator of such
p.000067: establish- ment.
p.000067: (b) The owner or operator shall iden- tify the device activities of the estab- lishment such as
p.000067: manufacturing, re- packaging, or distributing devices.
p.000067: (c) Each owner or operator is re- quired to maintain a listing of all offi- cers, directors, and
p.000067: partners for each establishment he registers and to fur- nish this information to the Food and Drug
p.000067: Administration upon request.
p.000067: (d) Each owner or operator shall pro- vide the name of an official cor- respondent who will serve as
p.000067: a point of contact between the Food and Drug Administration and the establishment for matters relating to
p.000067: the registration of device establishments and the list- ing of device products. All future cor- respondence
p.000067: relating to registration, including requests for the names of partners, officers, and directors, will be
p.000067: directed to this official correspondent. In the event no person is designated by the owner or operator, the owner
p.000067: or op- erator of the establishment will be the official correspondent.
p.000067: (e) The designation of an official cor-
p.000067: respondent does not in any manner af- fect the liability of the owner or oper- ator of the
p.000067: establishment or any other individual under section 301(p) or any other provision of the act.
p.000067: (f) Form FD–2892 is the approved form for providing the device listing information required by the
p.000067: act. This required information includes the fol- lowing:
p.000067: (1) The identification by classifica- tion name and number, proprietary name, and common or usual
p.000067: name of each device being manufactured, pre- pared, propagated, compounded, or processed for commercial
p.000067: distribution that has not been included in any list
p.000067:
p.000067:
p.000067:
p.000067:
p.000067:
p.000067:
p.000067:
p.000067:
p.000067: § 807.26
p.000067: of devices previously submitted on form FDA–2892.
p.000067: (2) The Code of Federal Regulations citation for any applicable standard for the device under section 514 of
p.000067: the act or section 358 of the Public Health Service Act.
p.000067: (3) The assigned Food and Drug Ad- ministration number of the approved application for each device listed
p.000067: that is subject to section 505 or 515 of the act.
p.000067: (4) The name, registration number, and establishment type of every domes- tic or foreign device
p.000067: establishment under joint ownership and control of the owner or operator at which the de- vice is
p.000067: manufactured, repackaged, or relabeled.
p.000067: (5) Whether the device, as labeled, is intended for distribution to and use by the general public.
p.000067: (6) Other general information re- quested on form FDA–2892, i.e.,
p.000067: (i) If the submission refers to a pre- viously listed device, as in the case of an update, the
p.000067: document number from the initial listing document for the de- vice,
p.000067: (ii) The reason for submission,
p.000067: (iii) The date on which the reason for submission occurred,
p.000067: (iv) The date that the form FDA–2892 was completed,
p.000067: (v) The owner’s or operator’s name and identification number.
p.000067: (7) Labeling or other descriptive in- formation (e.g., specification sheets or catalogs) adequate to
p.000067: describe the in- tended use of a device when the owner or operator is unable to find an appro- priate
p.000067: FDA classification name for the device.
p.000067: [42 FR 42526, Aug. 23, 1977, as amended at 43
p.000067: FR 37998, Aug. 25, 1978; 58 FR 46523, Sept. 1,
p.000067: 1993; 64 FR 404, Jan. 5, 1999; 66 FR 59160, Nov.
p.000067: 27, 2001; 69 FR 11312, Mar. 10, 2004]
p.000067:
p.000067: § 807.26 Amendments to establishment registration.
p.000067: Changes in individual ownership, cor- porate or partnership structure, or lo- cation of an operation
p.000067: defined in
p.000067: § 807.3(c) shall be submitted on Form FDA–2891(a) at the time of annual reg- istration, or by letter if
p.000067: the changes occur at other times. This information shall be submitted within 30 days of such changes.
p.000067: Changes in the names of
p.000067:
p.000068: 68
p.000068: 21 CFR Ch. I (4–1–12 Edition)
p.000068: officers and/or directors of the corpora- tion(s) shall be filed with the establish- ment’s official correspondent
p.000068: and shall be provided to the Food and Drug Ad- ministration upon receipt of a written request for this
p.000068: information.
p.000068: [69 FR 11312, Mar. 10, 2004]
p.000068:
p.000068: § 807.30 Updating device listing infor- mation.
p.000068: (a) Form FDA–2892 shall be used to update device listing information. The preprinted original document
p.000068: number of each form FDA–2892 on which the de- vice was initially listed shall appear on the form subsequently used
p.000068: to update the listing information for the device and on any correspondence related to the device.
p.000068: (b) An owner or operator shall update the device listing information during each June and December or, at its
p.000068: dis- cretion, at the time the change occurs. Conditions that require updating and information to be submitted for
p.000068: each of these updates are as follows:
p.000068: (1) If an owner or operator introduces into commercial distribution a device identified with a classification
p.000068: name not currently listed by the owner or operator, then the owner or operator must submit form FDA–2892
p.000068: containing all the information required by
p.000068: § 807.25(f).
p.000068: (2) If an owner or operator discon- tinues commercial distribution of all devices in the same device
p.000068: class, i.e., with the same classification name, the owner or operator must submit form FDA–2892 containing
p.000068: the original docu- ment number of the form FDA–2892 on which the device class was initially listed,
p.000068: the reason for submission, the date of discontinuance, the owner or operator’s name and
p.000068: identification number, the classification name and number, the proprietary name, and the common or usual
p.000068: name of the discon- tinued device.
p.000068: (3) If commercial distribution of a discontinued device identified on a form FDA–2892 filed
p.000068: under paragraph (b)(2) of this section is resumed, the owner or operator must submit on form FDA–2892 a
p.000068: notice of resumption con- taining: the original document number of the form initially used to list that
p.000068: device class, the reason for submission,
p.000068:
p.000068:
p.000068:
p.000068:
p.000068:
p.000068:
p.000068:
p.000068: Food and Drug Administration, HHS § 807.31
p.000068:
p.000068:
p.000068: date of resumption, and all other infor- mation required by § 807.25(f).
p.000068: (4) If one or more classification names for a previously listed device with multiple
p.000068: classification names has been added or deleted, the owner or op- erator must supply the original docu- ment
p.000068: number from the form FDA–2892 on which the device was initially listed and a supplemental sheet identifying the
p.000068: names of any new or deleted classi- fication names.
p.000068: (5) Other changes to information on form FDA–2892 will be updated as fol- lows:
p.000068: (i) Whenever a change occurs only in the owner or operator name or number, e.g., whenever one company’s
p.000068: device line is purchased by another owner or operator, it will not be necessary to supply a separate
p.000068: form FDA–2892 for each device. In such cases, the new owner or operator must follow the pro- cedures
p.000068: in § 807.26 and submit a letter informing the Food and Drug Adminis- tration of the original document num-
p.000068: ber from form FDA–2892 on which each device was initially listed for those de- vices affected by the change
p.000068: in owner- ship.
p.000068: (ii) The owner or operator must also submit update information whenever establishment registration
p.000068: numbers, establishment names, and/or activities are added to or deleted from form FDA 2892. The owner or
p.000068: operator must sup- ply the original document number from the form FDA–2892 on which the device was initially listed,
p.000068: the reason for sub- mission, and all other information re- quired by § 807.25(f).
p.000068: (6) Updating is not required if the above information has not changed since the previously
p.000068: submitted list. Also, updating is not required if changes occur in proprietary names, in common or
p.000068: usual names, or to supple- mental lists of unclassified components or accessories.
p.000068: [69 FR 11312, Mar. 10, 2004]
p.000068: § 807.31 Additional listing information.
p.000068: (a) Each owner or operator shall maintain a historical file containing the labeling and
p.000068: advertisements in use on the date of initial listing, and in use after October 10, 1978, but before the date of
p.000068: initial listing, as follows:
p.000068:
p.000069: 69
p.000069:
p.000069: (1) For each device subject to section
p.000069: 514 or 515 of the act that is not a re- stricted device, a copy of all labeling for the device;
p.000069: (2) For each restricted device, a copy of all labeling and advertisements for the device;
p.000069: (3) For each device that is neither re- stricted nor subject to section 514 or
p.000069: 515 of the act, a copy of all labels, package inserts, and a representative sampling of any other
p.000069: labeling.
p.000069: (b) In addition to the requirements set forth in paragraph (a) of this sec- tion, each owner or
p.000069: operator shall maintain in the historical file any la- beling or advertisements in which a material
p.000069: change has been made any- time after initial listing.
p.000069: (c) Each owner or operator may dis- card labeling and advertisements from the historical file 3 years after
p.000069: the date of the last shipment of a discontinued device by an owner or operator.
p.000069: (d) Location of the file:
p.000069: (1) Currently existing systems for maintenance of labeling and adver- tising may be used for the
p.000069: purpose of maintaining the historical file as long as the information included in the sys- tems fulfills the
p.000069: requirements of this section, but only if the labeling and ad- vertisements are retrievable in a time- ly manner.
p.000069: (2) The contents of the historical file may be physically located in more than one place in the establishment or
p.000069: in more than one establishment provided there exists joint ownership and con- trol among all the
p.000069: establishments maintaining the historical file. If no joint ownership and control exists, the registered
p.000069: establishment must provide the Food and Drug Administration with a letter authorizing the establish- ment
p.000069: outside its control to maintain the historical file.
p.000069: (3) A copy of the certification and
p.000069: disclosure statements as required by part 54 of this chapter shall be retained and physically located at the
p.000069: establish- ment maintaining the historical file.
p.000069: (e) Each owner or operator shall be prepared to submit to the Food and Drug Administration, only
p.000069: upon spe- cific request, the following informa- tion:
p.000069: (1) For a device subject to section 514 or 515 of the act that is not a restricted
p.000069:
p.000069:
p.000069:
p.000069:
p.000069:
p.000069:
p.000069:
p.000069:
p.000069: § 807.35
p.000069: device, a copy of all labeling for the de- vice.
p.000069: (2) For a device that is a restricted device, a copy of all labeling for the de- vice, a representative
p.000069: sampling of ad- vertisements for the device, and for good cause, a copy of all advertise- ments
p.000069: for a particular device. A re- quest for all advertisements will, where feasible, be accompanied by an
p.000069: expla- nation of the basis for such request.
p.000069: (3) For a device that is neither a re- stricted device, nor subject to section 514 of 515 of the act, the
p.000069: label and pack- age insert for the device and a rep- resentative sampling of any other la- beling
p.000069: for the device.
p.000069: (4) For a particular device, a state- ment of the basis upon which the reg- istrant has determined that
p.000069: the device is not subject to section 514 or 515 of the act.
p.000069: (5) For a particular device, a state- ment of the basis upon which the reg- istrant has determined
p.000069: the device is not a restricted device.
p.000069: (6) For a particular device, a state- ment of the basis for determining that the product is a device
p.000069: rather than a drug.
p.000069: (7) For a device that the owner or op- erator has manufactured for distribu- tion under a label other than
p.000069: its own, the names of all distributors for whom it has been manufactured.
p.000069: [43 FR 37999, Aug. 25, 1978, as amended at 51
p.000069: FR 33033, Sept. 18, 1986; 63 FR 5253, Feb. 2,
p.000069: 1998]
p.000069: § 807.35 Notification of registrant.
p.000069: (a) The Commissioner will provide to the official correspondent, at the ad- dress listed on the form, a
p.000069: validated copy of Form FDA–2891 or Form FDA– 2891(a) (whichever is applicable) as evi- dence of registration. A
p.000069: permanent reg- istration number will be assigned to each device establishment registered in accordance with
p.000069: these regulations.
p.000069: (b) Owners and operators of device es-
p.000069: tablishments who also manufacture or process blood or drug products at the same establishment shall also
p.000069: register with the Center for Biologics Evalua- tion and Research and Center for Drug Evaluation and
p.000069: Research, as appro- priate. Blood products shall be listed with the Center for Biologics Evalua- tion
p.000069: and Research, Food and Drug Ad-
p.000069:
p.000070: 70
p.000070: 21 CFR Ch. I (4–1–12 Edition)
p.000070: ministration, pursuant to part 607 of this chapter; drug products shall be listed with the Center for
p.000070: Drug Evalua- tion and Research, Food and Drug Ad- ministration, pursuant to part 207 of this chapter.
p.000070: (c) Although establishment registra- tion and device listing are required to engage in the device
p.000070: activities de- scribed in § 807.20, validation of reg- istration and the assignment of a de- vice
p.000070: listing number in itself does not establish that the holder of the reg- istration is legally qualified
p.000070: to deal in such devices and does not represent a determination by the Food and Drug Administration as to
p.000070: the status of any device.
p.000070: [69 FR 11312, Mar. 10, 2004]
p.000070:
p.000070: § 807.37 Inspection of establishment registration and device listings.
p.000070: (a) A copy of the forms FDA–2891 and FDA–2891a filed by the registrant will be available for inspection in
p.000070: accord- ance with section 510(f) of the act, at the Food and Drug Administration, Center for Devices
p.000070: and Radiological Health, Office of Compliance, 10903 New Hampshire Ave., Bldg. 66, rm. 3521, Sil- ver Spring, MD
p.000070: 20993–0002. In addition, there will be available for inspection at each of the Food and Drug Administra- tion
p.000070: district offices the same informa- tion for firms within the geographical area of such district office.
p.000070: Upon re- quest, verification of registration num- ber or location of a registered estab- lishment will be
p.000070: provided.
p.000070: (b)(1) The following information filed
p.000070: under the device listing requirements will be available for public disclosure:
p.000070: (i) Each form FDA–2892 submitted;
p.000070: (ii) All labels submitted;
p.000070: (iii) All labeling submitted;
p.000070: (iv) All advertisements submitted;
p.000070: (v) All data or information that has already become a matter of public knowledge.
p.000070: (2) Requests for device listing infor- mation identified in paragraph (b)(1) of this section should be
p.000070: directed to the Food and Drug Administration, Center for Devices and Radiological Health, Office of
p.000070: Compliance, 10903 New Hamp- shire Ave., Bldg. 66, rm. 3521, Silver Spring, MD 20993–0002.
p.000070: (3) Requests for device listing infor-
p.000070: mation not identified in paragraph
p.000070:
p.000070:
p.000070:
p.000070:
p.000070:
p.000070:
p.000070:
p.000070: Food and Drug Administration, HHS § 807.65
p.000070:
p.000070:
p.000070: (b)(1) of this section shall be submitted and handled in accordance with part 20 of this chapter.
p.000070: [69 FR 11313, Mar. 10, 2004, as amended at 75
p.000070: FR 20914, Apr. 22, 2010]
p.000070:
p.000070: § 807.39 Misbranding by reference to establishment registration or to registration number.
p.000070: Registration of a device establish- ment or assignment of a registration number does not in any way denote
p.000070: ap- proval of the establishment or its prod- ucts. Any representation that creates an impression of official
p.000070: approval be- cause of registration or possession of a registration number is misleading and constitutes
p.000070: misbranding.
p.000070:
p.000070: Subpart C—Registration Proce- dures for Foreign Device Es- tablishments
p.000070: § 807.40 Establishment registration and device listing for foreign estab- lishments importing or offering
p.000070: for import devices into the United States.
p.000070: (a) Any establishment within any foreign country engaged in the manu- facture, preparation,
p.000070: propagation, compounding, or processing of a device that is imported or offered for import into the United
p.000070: States shall register and list such devices in conformance with the requirements in subpart B of this part
p.000070: unless the device enters a for- eign trade zone and is re-exported from that foreign trade zone without having entered
p.000070: U. S. commerce. The official correspondent for the foreign establish- ment shall facilitate communication
p.000070: between the foreign establishment’s management and representatives of the Food and Drug Administration
p.000070: for matters relating to the registration of device establishments and the listing of device products.
p.000070: (b) Each foreign establishment re- quired to register under paragraph (a) of this section shall submit
p.000070: the name, address, and phone number of its United States agent as part of its ini- tial and
p.000070: updated registration informa- tion in accordance with subpart B of this part. Each foreign establishment
p.000070: shall designate only one United States agent and may designate the United
p.000070:
p.000071: 71
p.000071:
p.000071: States agent to act as its official cor- respondent.
p.000071: (1) The United States agent shall re- side or maintain a place of business in the United States.
p.000071: (2) Upon request from FDA, the United States agent shall assist FDA in communications with the
p.000071: foreign es- tablishment, respond to questions con- cerning the foreign establishment’s products that are
p.000071: imported or offered for import into the United States, and assist FDA in scheduling inspections of the
p.000071: foreign establishment. If the agen- cy is unable to contact the foreign es- tablishment directly or
p.000071: expeditiously, FDA may provide information or docu- ments to the United States agent, and such an action shall be
p.000071: considered to be equivalent to providing the same infor- mation or documents to the foreign es- tablishment.
p.000071: (3) The foreign establishment or the
p.000071: United States agent shall report changes in the United States agent’s name, address, or
p.000071: phone number to FDA within 10-business days of the change.
...
p.000071: name of the pharmacy.
p.000071: (f) Persons who manufacture, pre- pare, propagate, compound, or process devices solely for use
p.000071: in research, teaching, or analysis and do not intro- duce such devices into commercial dis- tribution.
p.000071: (g) [Reserved]
p.000071: (h) Carriers by reason of their re- ceipt, carriage, holding or delivery of devices in the usual
p.000071: course of business as carriers.
p.000071: (i) Persons who dispense devices to the ultimate consumer or whose major responsibility is to render
p.000071: a service necessary to provide the consumer (i.e., patient, physician, layman, etc.) with a device or the
p.000071: benefits to be derived from the use of a device; for example, a hearing aid dispenser, optician, clinical
p.000071: laboratory, assembler of diagnostic x- ray systems, and personnel from a hos- pital, clinic, dental
p.000071: laboratory, orthotic or prosthetic retail facility, whose primary responsibility to the ul-
p.000072: 72
p.000072: 21 CFR Ch. I (4–1–12 Edition)
p.000072: timate consumer is to dispense or pro- vide a service through the use of a pre- viously manufactured device.
p.000072: [42 FR 42526, Aug. 23, 1977, as amended at 58
p.000072: FR 46523, Sept. 1, 1993; 61 FR 44615, Aug. 28,
p.000072: 1996; 65 FR 17136, Mar. 31, 2000; 66 FR 59160,
p.000072: Nov. 27, 2001]
p.000072:
p.000072: Subpart E—Premarket Notification Procedures
p.000072: § 807.81 When a premarket notification submission is required.
p.000072: (a) Except as provided in paragraph
p.000072: (b) of this section, each person who is required to register his establishment pursuant to § 807.20 must
p.000072: submit a pre- market notification submission to the Food and Drug Administration at least 90 days before he
p.000072: proposes to begin the introduction or delivery for introduc- tion into interstate commerce for com- mercial
p.000072: distribution of a device in- tended for human use which meets any of the following criteria:
p.000072: (1) The device is being introduced into commercial distribution for the first time; that is, the
p.000072: device is not of the same type as, or is not substan- tially equivalent to, (i) a device in
p.000072: commercial distribution before May 28, 1976, or (ii) a device introduced for commercial distribution
p.000072: after May 28, 1976, that has subsequently been reclas- sified into class I or II.
p.000072: (2) The device is being introduced into commercial distribution for the first time by a person
p.000072: required to reg- ister, whether or not the device meets the criteria in paragraph (a)(1) of this section.
p.000072: (3) The device is one that the person currently has in commercial distribu- tion or is reintroducing
p.000072: into commer- cial distribution, but that is about to be significantly changed or modified in design,
p.000072: components, method of manu- facture, or intended use. The following constitute significant changes or modi-
p.000072: fications that require a premarket no- tification:
p.000072: (i) A change or modification in the device that could significantly affect the safety or effectiveness of
p.000072: the de- vice, e.g., a significant change or modi- fication in design, material, chemical composition, energy
p.000072: source, or manu- facturing process.
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072: Food and Drug Administration, HHS § 807.87
p.000072:
p.000072:
p.000072: (ii) A major change or modification in the intended use of the device.
p.000072: (b)(1) A premarket notification under this subpart is not required for a device for which a premarket approval
p.000072: appli- cation under section 515 of the act, or for which a petition to reclassify under section 513(f)(2) of
p.000072: the act, is pending before the Food and Drug Administra- tion.
p.000072: (2) The appropriate FDA Center Di- rector may determine that the submis- sion and grant of a written request
p.000072: for an exception or alternative under
p.000072: § 801.128 or § 809.11 of this chapter satis- fies the requirement in paragraph (a)(3) of this section.
p.000072: (c) In addition to complying with the requirements of this part, owners or operators of device establishments
p.000072: that manufacture radiation-emitting elec- tronic products, as defined in § 1000.3 of this chapter, shall comply
p.000072: with the re- porting requirements of part 1002 of this chapter.
p.000072: [42 FR 42526, Aug. 23, 1977, as amended at 72
p.000072: FR 73601, Dec. 28, 2007]
p.000072:
p.000072: § 807.85 Exemption from premarket notification.
p.000072: (a) A device is exempt from the pre- market notification requirements of this subpart if the device
p.000072: intended for introduction into commercial distribu- tion is not generally available in fin- ished form for
p.000072: purchase and is not of- fered through labeling or advertising by the manufacturer, importer, or dis-
p.000072: tributor thereof for commercial dis- tribution, and the device meets one of the following conditions:
p.000072: (1) It is intended for use by a patient named in the order of the physician or dentist (or other specially
p.000072: qualified person); or
p.000072: (2) It is intended solely for use by a physician or dentist (or other specially qualified person) and is
p.000072: not generally available to, or generally used by, other physicians or dentists (or other specially
p.000072: qualified persons).
p.000072: (b) A distributor who places a device into commercial distribution for the first time under his own name
...
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073: § 807.90
p.000073: use, the premarket notification sub- mission must include appropriate sup- porting data to show that the
p.000073: manufac- turer has considered what con- sequences and effects the change or modification or
p.000073: new use might have on the safety and effectiveness of the de- vice.
p.000073: (h) A 510(k) summary as described in
p.000073: § 807.92 or a 510(k) statement as de- scribed in § 807.93.
p.000073: (i) A financial certification or disclo- sure statement or both, as required by part 54 of this chapter.
p.000073: (j) For submissions claiming substan- tial equivalence to a device which has been classified into class III
p.000073: under sec- tion 513(b) of the act:
p.000073: (1) Which was introduced or delivered for introduction into interstate com- merce for commercial distribution
p.000073: be- fore December 1, 1990; and
p.000073: (2) For which no final regulation re- quiring premarket approval has been issued under section 515(b) of the
p.000073: act, a summary of the types of safety and ef- fectiveness problems associated with the type of devices
p.000073: being compared and a citation to the information upon which the summary is based (class III summary).
p.000073: The 510(k) submitter shall also certify that a reasonable search of all information known or otherwise
p.000073: available about the class III device and other similar legally marketed devices has been conducted (class III
p.000073: certifi- cation), as described in § 807.94. This in- formation does not refer to informa- tion that already has
p.000073: been submitted to the Food and Drug Administration (FDA) under section 519 of the act. FDA may
p.000073: require the submission of the adverse safety and effectiveness data described in the class III summary or
p.000073: citation.
p.000073: (k) A statement that the submitter
p.000073: believes, to the best of his or her knowledge, that all data and informa- tion submitted in the
p.000073: premarket notifi- cation are truthful and accurate and that no material fact has been omitted.
p.000073: (l) Any additional information re- garding the device requested by the Commissioner that is necessary
p.000073: for the Commissioner to make a finding as to whether or not the device is substan- tially equivalent to
p.000073: a device in com- mercial distribution. A request for ad- ditional information will advise the
p.000074: 74
p.000074: 21 CFR Ch. I (4–1–12 Edition)
p.000074: owner or operator that there is insuffi- cient information contained in the original premarket
p.000074: notification sub- mission for the Commissioner to make this determination and that the owner or operator
p.000074: may either submit the re- quested data or a new premarket noti- fication containing the requested infor-
p.000074: mation at least 90 days before the owner or operator intends to market the device, or submit a
p.000074: premarket ap- proval application in accordance with section 515 of the act. If the additional information
p.000074: is not submitted within 30 days following the date of the request, the Commissioner will consider the
p.000074: premarket notification to be with- drawn.
p.000074: (Information collection requirements in this section were approved by the Office of Man- agement and
p.000074: Budget (OMB) and assigned OMB control number 0910–0281)
p.000074: [42 FR 42526, Aug 23, 1977, as amended at 57
p.000074: FR 18066, Apr. 28, 1992; 59 FR 64295, Dec. 14,
p.000074: 1994; 63 FR 5253, Feb. 2, 1998]
p.000074:
p.000074: § 807.90 Format of a premarket notifi- cation submission.
p.000074: Each premarket notification submis- sion pursuant to this part shall be sub- mitted in accordance with this section.
p.000074: Each submission shall:
p.000074: (a)(1) For devices regulated by the Center for Devices and Radiological Health, be addressed to
p.000074: the Food and Drug Administration, Center for De- vices and Radiological Health, Docu- ment Mail
p.000074: Center, 10903 New Hamp- shire Ave., Bldg. 66, rm. G609, Silver Spring, MD 20993–0002.
p.000074: (2) For devices regulated by the Cen-
p.000074: ter for Biologics Evaluation and Re- search, be addressed to the Document Control Center (HFM–99),
p.000074: Center for Biologics Evaluation and Research, Food and Drug Administration, 1401 Rockville Pike,
p.000074: suite 200N, Rockville, MD 20852–1448; or for devices regulated by the Center for Drug Evaluation and
p.000074: Research, be addressed to the Central Document Room, Center for Drug Eval- uation and Research, Food and Drug
p.000074: Administration, 5901–B Ammendale Rd., Beltsville, MD 20705–1266. Informa- tion about devices regulated
p.000074: by the Center for Biologics Evaluation and Research is available at http://
p.000074: .fda.gov/cber/dap/devlst.htm on the
p.000074: Internet.
p.000074:
p.000074:
p.000074:
p.000074:
p.000074:
p.000074:
p.000074:
p.000074: Food and Drug Administration, HHS § 807.92
p.000074:
p.000074:
p.000074: (3) All inquiries regarding a pre- market notification submission should be in writing and sent to one of
p.000074: the ad- dresses above.
p.000074: (b) Be bound into a volume or vol- umes, where necessary.
p.000074: (c) Be submitted in duplicate on standard size paper, including the original and two copies
p.000074: of the cover letter.
p.000074: (d) Be submitted separately for each product the manufacturer intends to market.
p.000074: (e) Designated ‘‘510(k) Notification’’ in the cover letter.
p.000074: [42 FR 42526, Aug. 23, 1977, as amended at 53
p.000074: FR 11252, Apr. 6, 1988; 55 FR 11169, Mar. 27,
p.000074: 1990; 65 FR 17137, Mar. 31, 2000; 70 FR 14986,
p.000074: Mar. 24, 2005; 75 FR 20915, Apr. 22, 2010]
p.000074:
p.000074: § 807.92 Content and format of a 510(k) summary.
p.000074: (a) A 510(k) summary shall be in suf- ficient detail to provide an under- standing of the basis
p.000074: for a determina- tion of substantial equivalence. FDA will accept summaries as well as
p.000074: amendments thereto until such time as FDA issues a determination of substan- tial equivalence. All 510(k) summaries
p.000074: shall contain the following informa- tion:
p.000074: (1) The submitter’s name, address,
p.000074: telephone number, a contact person, and the date the summary was pre- pared;
p.000074: (2) The name of the device, including the trade or proprietary name if appli- cable, the common or usual
p.000074: name, and the classification name, if known;
p.000074: (3) An identification of the legally marketed device to which the sub- mitter claims
...
p.000076: tion submissions for which substantial equivalence determinations have been made.
p.000076: (c) The information provided to re- questors will be a duplicate of the pre- market notification
p.000076: submission, in- cluding any adverse information, but excluding all patient identifiers, and trade
p.000076: secret and confidential commer- cial information as defined in § 20.61 of this chapter.
p.000076: [59 FR 64295, Dec. 14, 1994]
p.000076:
p.000076: § 807.94 Format of a class III certifi- cation.
p.000076: (a) A class III certification submitted as part of a premarket notification shall state as follows:
p.000076: I certify, in my capacity as (position held in company), of (company name), that I have conducted a reasonable
p.000076: search of all infor- mation known or otherwise available about the types and causes of safety or
p.000076: effective- ness problems that have been reported for the (type of device). I further certify that I am
p.000076: aware of the types of problems to which the (type of device) is susceptible and that, to the best of
p.000076: my knowledge, the following summary of the types and causes of safety or effectiveness problems about the (type of
p.000076: de- vice) is complete and accurate.
p.000076: (b) The statement in paragraph (a) of this section should be signed by the certifier, clearly identified as
p.000076: ‘‘class III certification,’’ and included at the be- ginning of the section of the premarket notification
p.000076: submission that sets forth the class III summary.
p.000076: [59 FR 64296, Dec. 14, 1994]
p.000076: § 807.95 Confidentiality of information.
p.000076: (a) The Food and Drug Administra- tion will disclose publicly whether there exists a premarket
p.000076: notification submission under this part:
p.000076: (1) Where the device is on the mar- ket, i.e., introduced or delivered for in- troduction into interstate
p.000076: commerce for commercial distribution;
p.000076: (2) Where the person submitting the premarket notification submission has disclosed, through advertising or
p.000076: any other manner, his intent to market the device to scientists, market analysts, exporters, or other individuals
p.000076: who are not employees of, or paid consultants to, the establishment and who are not in an advertising or
p.000076: law firm pursuant
p.000076:
p.000076:
p.000076:
p.000076:
p.000076:
p.000076:
p.000076:
p.000076: Food and Drug Administration, HHS § 807.95
p.000076:
p.000076:
p.000076: to commercial arrangements with ap- propriate safeguards for secrecy; or
p.000076: (3) Where the device is not on the market and the intent to market the device has not been so disclosed,
p.000076: except where the submission is subject to an exception under paragraph (b) or (c) of this section.
p.000076: (b) The Food and Drug Administra- tion will not disclose publicly the ex- istence of a premarket
p.000076: notification submission for a device that is not on the market and where the intent to market the
p.000076: device has not been dis- closed for 90 days from the date of re- ceipt of the submission, if:
p.000076: (1) The person submitting the pre- market notification submission re- quests in the submission that
p.000076: the Food and Drug Administration hold as con- fidential commercial information the intent to market the
p.000076: device and sub- mits a written certification to the Commissioner:
p.000076: (i) That the person considers his in- tent to market the device to be con- fidential commercial
p.000076: information;
p.000076: (ii) That neither the person nor, to the best of his knowledge, anyone else, has disclosed through
p.000076: advertising or any other manner, his intent to mar- ket the device to scientists, market an- alysts,
p.000076: exporters, or other individuals, except employees of, or paid consult- ants to, the establishment or
p.000076: individ- uals in an advertising or law firm pur- suant to commercial arrangements with appropriate
p.000076: safeguards for se- crecy;
p.000076: (iii) That the person will imme- diately notify the Food and Drug Ad- ministration if he
p.000076: discloses the intent to market the device to anyone, except employees of, or paid consultants to, the
p.000076: establishment or individuals in an advertising or law firm pursuant to commercial arrangements with
p.000076: appro- priate safeguards for secrecy;
p.000076: (iv) That the person has taken pre- cautions to protect the confidentiality of the intent to market the
p.000076: device; and
p.000076: (v) That the person understands that the submission to the government of false information is
p.000076: prohibited by 18
p.000076: U.S.C. 1001 and 21 U.S.C. 331(q); and
p.000076: (2) The Commissioner agrees that the intent to market the device is con- fidential commercial information.
p.000076:
p.000077: 77
p.000077:
p.000077: (c) Where the Commissioner deter- mines that the person has complied with the procedures described
p.000077: in para- graph (b) of this section with respect to a device that is not on the market and where the intent to
p.000077: market the device has not been disclosed, and the Com- missioner agrees that the intent to market
p.000077: the device is confidential com- mercial information, the Commissioner will not disclose the existence of the
p.000077: submission for 90 days from the date of its receipt by the agency. In addition, the Commissioner will continue
p.000077: not to disclose the existence of such a submis- sion for the device for an additional time when any of the
p.000077: following occurs:
p.000077: (1) The Commissioner requests in writing additional information regard- ing the device pursuant to §
p.000077: 807.87(h), in which case the Commissioner will not disclose the existence of the submis- sion until 90
p.000077: days after the Food and Drug Administration’s receipt of a complete premarket notification sub-
p.000077: mission;
p.000077: (2) The Commissioner determines that the device intended to be intro- duced is a class III device
p.000077: and cannot be marketed without premarket ap- proval or reclassification, in which case the
p.000077: Commissioner will not dis- close the existence of the submission unless a petition for reclassification
p.000077: is submitted under section 513(f)(2) of the act and its existence can be disclosed under § 860.5(d) of this
p.000077: chapter; or
p.000077: (d) FDA will make a 510(k) summary of the safety and effectiveness data available to the public
p.000077: within 30 days of the issuance of a determination that the device is substantially equivalent to another
p.000077: device. Accordingly, even when a 510(k) submitter has complied with the conditions set forth in para-
p.000077: graphs (b) and (c) of this section, con- fidentiality for a premarket notifica- tion submission cannot be
p.000077: granted be- yond 30 days after FDA issues a deter- mination of equivalency.
p.000077: (e) Data or information submitted with, or incorporated by reference in, a premarket notification
p.000077: submission (other than safety and effectiveness data that have not been disclosed to
p.000077:
p.000077:
p.000077:
p.000077:
p.000077:
p.000077:
p.000077:
p.000077:
p.000077: § 807.97
p.000077: the public) shall be available for disclo- sure by the Food and Drug Administra- tion when the intent to market the de-
p.000077: vice is no longer confidential in accord- ance with this section, unless exempt from public disclosure in
p.000077: accordance with part 20 of this chapter. Upon final classification, data and information re- lating to safety and
p.000077: effectiveness of a device classified in class I (general con- trols) or class II (performance stand- ards)
p.000077: shall be available for public dis- closure. Data and information relating to safety and effectiveness of
p.000077: a device classified in class III (premarket ap- proval) that have not been released to the public shall
p.000077: be retained as con- fidential unless such data and informa- tion become available for release to the public
p.000077: under § 860.5(d) or other provi- sions of this chapter.
p.000077: [42 FR 42526, Aug. 23, 1977, as amended at 53
p.000077: FR 11252, Apr. 6, 1988; 57 FR 18067, Apr. 28,
p.000077: 1992; 59 FR 64296, Dec. 14, 1994]
p.000077:
p.000077: § 807.97 Misbranding by reference to premarket notification.
p.000077: Submission of a premarket notifica- tion in accordance with this subpart, and a subsequent determination by
p.000077: the Commissioner that the device intended for introduction into commercial dis- tribution is substantially
p.000077: equivalent to a device in commercial distribution be- fore May 28, 1976, or is substantially equivalent to a
p.000077: device introduced into commercial distribution after May 28, 1976, that has subsequently been reclas- sified into
p.000077: class I or II, does not in any way denote official approval of the de- vice. Any representation that creates
p.000077: an impression of official approval of a device because of complying with the premarket notification
...
Health / Physically Disabled
Searching for indicator physically:
(return to top)
p.000064: information in a premarket notification submission re- garding safety and effectiveness will be made available
p.000064: within 30 days of re- quest by any person if the device de- scribed in the premarket notification
p.000064: submission is determined to be sub- stantially equivalent. The information to be made available will be a
p.000064: duplicate of the premarket notification submis- sion, including any adverse safety and effectiveness
p.000064: information, but exclud- ing all patient identifiers, and trade se- cret or confidential commercial infor-
p.000064: mation, as defined in § 20.61 of this chapter.
p.000064: (p) Class III certification means a cer- tification that the submitter of the 510(k) has
p.000064: conducted a reasonable search of all known information about the class III device and other similar,
p.000064: legally marketed devices.
p.000064: (q) Class III summary means a sum- mary of the types of safety and effec- tiveness problems associated
p.000064: with the type of device being compared and a ci- tation to the information upon which the summary is based.
p.000064: The summary must be comprehensive and describe the problems to which the type of de- vice is
p.000064: susceptible and the causes of such problems.
p.000064: (r) United States agent means a person residing or maintaining a place of busi- ness in the United States whom a
p.000064: for- eign establishment designates as its agent. This definition excludes mail- boxes, answering
p.000064: machines or services, or other places where an individual
p.000064:
p.000065: 65
p.000065:
p.000065: acting as the foreign establishment’s agent is not physically present.
p.000065: (s) Wholesale distributor means any person (other than the manufacturer or the initial importer) who
p.000065: distributes a device from the original place of manu- facture to the person who makes the final delivery or
p.000065: sale of the device to the ultimate consumer or user.
p.000065: [42 FR 42526, Aug. 23, 1977, as amended at 43
p.000065: FR 37997, Aug. 25, 1978; 57 FR 18066, Apr. 28,
p.000065: 1992; 58 FR 46522, Sept. 1, 1993; 59 FR 64295,
p.000065: Dec. 14, 1994; 60 FR 63606, Dec. 11, 1995; 63 FR
p.000065: 51826, Sept. 29, 1998; 66 FR 59159, Nov. 27, 2001]
p.000065:
p.000065: Subpart B—Procedures for Device Establishments
p.000065: § 807.20 Who must register and submit a device list?
p.000065: (a) An owner or operator of an estab- lishment not exempt under section 510(g) of the act or subpart D
p.000065: of this part who is engaged in the manufac- ture, preparation, propagation, compounding,
p.000065: assembly, or processing of a device intended for human use shall register and submit listing infor-
p.000065: mation for those devices in commercial distribution, except that registration and listing information may
p.000065: be sub- mitted by the parent, subsidiary, or af- filiate company for all the domestic or foreign establishments
p.000065: under the con- trol of one of these organizations when operations are conducted at more than one
p.000065: establishment and there exists joint ownership and control among all the establishments. The term
p.000065: ‘‘device’’ includes all in vitro diagnostic prod- ucts and in vitro diagnostic biological products not
...
p.000068: advertisements in use on the date of initial listing, and in use after October 10, 1978, but before the date of
p.000068: initial listing, as follows:
p.000068:
p.000069: 69
p.000069:
p.000069: (1) For each device subject to section
p.000069: 514 or 515 of the act that is not a re- stricted device, a copy of all labeling for the device;
p.000069: (2) For each restricted device, a copy of all labeling and advertisements for the device;
p.000069: (3) For each device that is neither re- stricted nor subject to section 514 or
p.000069: 515 of the act, a copy of all labels, package inserts, and a representative sampling of any other
p.000069: labeling.
p.000069: (b) In addition to the requirements set forth in paragraph (a) of this sec- tion, each owner or
p.000069: operator shall maintain in the historical file any la- beling or advertisements in which a material
p.000069: change has been made any- time after initial listing.
p.000069: (c) Each owner or operator may dis- card labeling and advertisements from the historical file 3 years after
p.000069: the date of the last shipment of a discontinued device by an owner or operator.
p.000069: (d) Location of the file:
p.000069: (1) Currently existing systems for maintenance of labeling and adver- tising may be used for the
p.000069: purpose of maintaining the historical file as long as the information included in the sys- tems fulfills the
p.000069: requirements of this section, but only if the labeling and ad- vertisements are retrievable in a time- ly manner.
p.000069: (2) The contents of the historical file may be physically located in more than one place in the establishment or
p.000069: in more than one establishment provided there exists joint ownership and con- trol among all the
p.000069: establishments maintaining the historical file. If no joint ownership and control exists, the registered
p.000069: establishment must provide the Food and Drug Administration with a letter authorizing the establish- ment
p.000069: outside its control to maintain the historical file.
p.000069: (3) A copy of the certification and
p.000069: disclosure statements as required by part 54 of this chapter shall be retained and physically located at the
p.000069: establish- ment maintaining the historical file.
p.000069: (e) Each owner or operator shall be prepared to submit to the Food and Drug Administration, only
p.000069: upon spe- cific request, the following informa- tion:
p.000069: (1) For a device subject to section 514 or 515 of the act that is not a restricted
p.000069:
p.000069:
p.000069:
p.000069:
p.000069:
p.000069:
p.000069:
p.000069:
p.000069: § 807.35
p.000069: device, a copy of all labeling for the de- vice.
p.000069: (2) For a device that is a restricted device, a copy of all labeling for the de- vice, a representative
p.000069: sampling of ad- vertisements for the device, and for good cause, a copy of all advertise- ments
p.000069: for a particular device. A re- quest for all advertisements will, where feasible, be accompanied by an
p.000069: expla- nation of the basis for such request.
p.000069: (3) For a device that is neither a re- stricted device, nor subject to section 514 of 515 of the act, the
p.000069: label and pack- age insert for the device and a rep- resentative sampling of any other la- beling
p.000069: for the device.
p.000069: (4) For a particular device, a state- ment of the basis upon which the reg- istrant has determined that
p.000069: the device is not subject to section 514 or 515 of the act.
p.000069: (5) For a particular device, a state- ment of the basis upon which the reg- istrant has determined
...
Social / Age
Searching for indicator age:
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p.000066: accordance with the schedule as described in
p.000066: § 807.21(a). The completed form shall be mailed to the address designated in this paragraph 30
p.000066: days after receipt from FDA.
p.000066: (b) The initial listing of devices and subsequent June and December updatings shall be on
p.000066: form FDA–2892 (Medical Device Listing). Forms are obtainable upon request as described in paragraph (a) of
p.000066: this section. A sepa- rate form FDA–2892 shall be submitted for each device or device class listed with
p.000066: the Food and Drug Administra- tion. Devices having variations in physical characteristics such as
p.000066: size, package, shape, color, or composition should be considered to be one device: Provided, The
p.000066: variation does not change the function or intended use of the device. In lieu of form FDA–2892,
p.000066: tapes for computer input or hard copy computer output may by submitted if equivalent in all elements of
p.000066: informa- tion as specified in form FDA–2892. All formats proposed for use in lieu of form FDA–2892 require
p.000066: initial review and ap- proval by the Food and Drug Adminis- tration.’’
p.000066: (c) The listing obligations of the ini- tial importer are satisfied as follows:
p.000066: (1) The initial importer is not re- quired to submit a form FDA-2892 for those devices for which such
p.000066: initial im- porter did not initiate or develop the specifications for the device or repack- age or relabel the
p.000066: device. However, the initial importer shall submit, for each device, the name and address of the
p.000066: manufacturer. Initial importers shall also be prepared to submit, when re- quested by FDA, the proprietary
p.000066: name, if any, and the common or usual name of each device for which they are the initial importers; and
p.000066: (2) The initial importer shall update the information required by paragraphs (c)(1) of this section at the
p.000066: intervals specified in § 807.30.
p.000066: [43 FR 37997, Aug. 25, 1978, as amended at 58
p.000066: FR 46522, Sept. 1, 1993; 60 FR 63606, Dec. 11,
p.000066: 1995; 63 FR 51826, Sept. 29, 1998; 69 FR 11311,
p.000066: Mar. 10, 2004; 69 FR 18473, Apr. 8, 2004; 69 FR
p.000066: 25489, May 7, 2004; 75 FR 20914, Apr. 22, 2010]
p.000066:
p.000067: 67
p.000067:
p.000067: § 807.25 Information required or re- quested for establishment registra- tion and device listing.
p.000067: (a) Form FDA–2891 and Form FDA– 2891(a) are the approved forms for ini- tially providing the
p.000067: information re- quired by the act and for providing an- nual registration, respectively. The re- quired
p.000067: information includes the name and street address of the device estab- lishment, including post office code,
p.000067: all trade names used by the establishment, and the business trading name of the owner or operator of such
p.000067: establish- ment.
p.000067: (b) The owner or operator shall iden- tify the device activities of the estab- lishment such as
p.000067: manufacturing, re- packaging, or distributing devices.
p.000067: (c) Each owner or operator is re- quired to maintain a listing of all offi- cers, directors, and
...
p.000069: establishment must provide the Food and Drug Administration with a letter authorizing the establish- ment
p.000069: outside its control to maintain the historical file.
p.000069: (3) A copy of the certification and
p.000069: disclosure statements as required by part 54 of this chapter shall be retained and physically located at the
p.000069: establish- ment maintaining the historical file.
p.000069: (e) Each owner or operator shall be prepared to submit to the Food and Drug Administration, only
p.000069: upon spe- cific request, the following informa- tion:
p.000069: (1) For a device subject to section 514 or 515 of the act that is not a restricted
p.000069:
p.000069:
p.000069:
p.000069:
p.000069:
p.000069:
p.000069:
p.000069:
p.000069: § 807.35
p.000069: device, a copy of all labeling for the de- vice.
p.000069: (2) For a device that is a restricted device, a copy of all labeling for the de- vice, a representative
p.000069: sampling of ad- vertisements for the device, and for good cause, a copy of all advertise- ments
p.000069: for a particular device. A re- quest for all advertisements will, where feasible, be accompanied by an
p.000069: expla- nation of the basis for such request.
p.000069: (3) For a device that is neither a re- stricted device, nor subject to section 514 of 515 of the act, the
p.000069: label and pack- age insert for the device and a rep- resentative sampling of any other la- beling
p.000069: for the device.
p.000069: (4) For a particular device, a state- ment of the basis upon which the reg- istrant has determined that
p.000069: the device is not subject to section 514 or 515 of the act.
p.000069: (5) For a particular device, a state- ment of the basis upon which the reg- istrant has determined
p.000069: the device is not a restricted device.
p.000069: (6) For a particular device, a state- ment of the basis for determining that the product is a device
p.000069: rather than a drug.
p.000069: (7) For a device that the owner or op- erator has manufactured for distribu- tion under a label other than
p.000069: its own, the names of all distributors for whom it has been manufactured.
p.000069: [43 FR 37999, Aug. 25, 1978, as amended at 51
p.000069: FR 33033, Sept. 18, 1986; 63 FR 5253, Feb. 2,
p.000069: 1998]
p.000069: § 807.35 Notification of registrant.
p.000069: (a) The Commissioner will provide to the official correspondent, at the ad- dress listed on the form, a
p.000069: validated copy of Form FDA–2891 or Form FDA– 2891(a) (whichever is applicable) as evi- dence of registration. A
p.000069: permanent reg- istration number will be assigned to each device establishment registered in accordance with
p.000069: these regulations.
p.000069: (b) Owners and operators of device es-
p.000069: tablishments who also manufacture or process blood or drug products at the same establishment shall also
...
Social / Incarcerated
Searching for indicator restricted:
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p.000063: as respon- sible for the following:
p.000063: (1) The annual registration of the es- tablishment;
p.000063: (2) Contact with the Food and Drug Administration for device listing;
p.000063: (3) Maintenance and submission of a current list of officers and directors to the Food and Drug
p.000063: Administration upon the request of the Commissioner;
p.000063: (4) The receipt of pertinent cor- respondence from the Food and Drug Administration directed to
p.000063: and involv- ing the owner or operator and/or any of the firm’s establishments; and
p.000063: (5) The annual certification of med- ical device reports required by § 804.30 of this chapter or
p.000063: forwarding the cer- tification form to the person des- ignated by the firm as responsible for
p.000063: the certification.
p.000063:
p.000064: 64
p.000064: 21 CFR Ch. I (4–1–12 Edition)
p.000064: (f) O ner or operator means the cor- poration, subsidiary, affiliated com- pany, partnership, or
p.000064: proprietor di- rectly responsible for the activities of the registering establishment.
p.000064: (g) Initial importer means any im- porter who furthers the marketing of a device from a foreign
p.000064: manufacturer to the person who makes the final deliv- ery or sale of the device to the ulti- mate
p.000064: consumer or user, but does not repackage, or otherwise change the container, wrapper, or labeling of
p.000064: the device or device package.
p.000064: (h) Any term defined in section 201 of the act shall have that meaning.
p.000064: (i) Restricted device means a device for which the Commissioner, by regulation under § 801.109 of this chapter or
p.000064: other- wise under section 520(e) of the act, has restricted sale, distribution, or use only upon the written
p.000064: or oral author- ization of a practitioner licensed by law to administer or use the device or upon
p.000064: such other conditions as the Com- missioner may prescribe.
p.000064: (j) Classification name means the term used by the Food and Drug Administra- tion and its classification panels to de-
p.000064: scribe a device or class of devices for purposes of classifying devices under section 513 of the act.
p.000064: (k) Representative sampling of adver- tisements means typical advertising ma- terial that gives the
p.000064: promotional claims made for the device.
p.000064: (l) Representative sampling of any other labeling means typical labeling mate- rial (excluding labels and
p.000064: package in- serts) that gives the promotional claims made for the device.
p.000064: (m) Material change includes any change or modification in the labeling or advertisements that
p.000064: affects the identity or safety and effectiveness of the device. These changes may include, but are not
p.000064: limited to, changes in the common or usual or proprietary name, declared ingredients or components, in- tended
p.000064: use, contraindications, warn- ings, or instructions for use. Changes that are not material may
p.000064: include graphic layouts, grammar, or correc- tion of typographical errors which do not change the content of
p.000064: the labeling, changes in lot number, and, for devices where the biological activity or known
p.000064:
p.000064:
p.000064:
p.000064:
p.000064:
p.000064:
p.000064:
...
p.000068: in § 807.26 and submit a letter informing the Food and Drug Adminis- tration of the original document num-
p.000068: ber from form FDA–2892 on which each device was initially listed for those de- vices affected by the change
p.000068: in owner- ship.
p.000068: (ii) The owner or operator must also submit update information whenever establishment registration
p.000068: numbers, establishment names, and/or activities are added to or deleted from form FDA 2892. The owner or
p.000068: operator must sup- ply the original document number from the form FDA–2892 on which the device was initially listed,
p.000068: the reason for sub- mission, and all other information re- quired by § 807.25(f).
p.000068: (6) Updating is not required if the above information has not changed since the previously
p.000068: submitted list. Also, updating is not required if changes occur in proprietary names, in common or
p.000068: usual names, or to supple- mental lists of unclassified components or accessories.
p.000068: [69 FR 11312, Mar. 10, 2004]
p.000068: § 807.31 Additional listing information.
p.000068: (a) Each owner or operator shall maintain a historical file containing the labeling and
p.000068: advertisements in use on the date of initial listing, and in use after October 10, 1978, but before the date of
p.000068: initial listing, as follows:
p.000068:
p.000069: 69
p.000069:
p.000069: (1) For each device subject to section
p.000069: 514 or 515 of the act that is not a re- stricted device, a copy of all labeling for the device;
p.000069: (2) For each restricted device, a copy of all labeling and advertisements for the device;
p.000069: (3) For each device that is neither re- stricted nor subject to section 514 or
p.000069: 515 of the act, a copy of all labels, package inserts, and a representative sampling of any other
p.000069: labeling.
p.000069: (b) In addition to the requirements set forth in paragraph (a) of this sec- tion, each owner or
p.000069: operator shall maintain in the historical file any la- beling or advertisements in which a material
p.000069: change has been made any- time after initial listing.
p.000069: (c) Each owner or operator may dis- card labeling and advertisements from the historical file 3 years after
p.000069: the date of the last shipment of a discontinued device by an owner or operator.
p.000069: (d) Location of the file:
p.000069: (1) Currently existing systems for maintenance of labeling and adver- tising may be used for the
p.000069: purpose of maintaining the historical file as long as the information included in the sys- tems fulfills the
p.000069: requirements of this section, but only if the labeling and ad- vertisements are retrievable in a time- ly manner.
p.000069: (2) The contents of the historical file may be physically located in more than one place in the establishment or
p.000069: in more than one establishment provided there exists joint ownership and con- trol among all the
p.000069: establishments maintaining the historical file. If no joint ownership and control exists, the registered
p.000069: establishment must provide the Food and Drug Administration with a letter authorizing the establish- ment
p.000069: outside its control to maintain the historical file.
p.000069: (3) A copy of the certification and
p.000069: disclosure statements as required by part 54 of this chapter shall be retained and physically located at the
p.000069: establish- ment maintaining the historical file.
p.000069: (e) Each owner or operator shall be prepared to submit to the Food and Drug Administration, only
p.000069: upon spe- cific request, the following informa- tion:
p.000069: (1) For a device subject to section 514 or 515 of the act that is not a restricted
p.000069:
p.000069:
p.000069:
p.000069:
p.000069:
p.000069:
p.000069:
p.000069:
p.000069: § 807.35
p.000069: device, a copy of all labeling for the de- vice.
p.000069: (2) For a device that is a restricted device, a copy of all labeling for the de- vice, a representative
p.000069: sampling of ad- vertisements for the device, and for good cause, a copy of all advertise- ments
p.000069: for a particular device. A re- quest for all advertisements will, where feasible, be accompanied by an
p.000069: expla- nation of the basis for such request.
p.000069: (3) For a device that is neither a re- stricted device, nor subject to section 514 of 515 of the act, the
p.000069: label and pack- age insert for the device and a rep- resentative sampling of any other la- beling
p.000069: for the device.
p.000069: (4) For a particular device, a state- ment of the basis upon which the reg- istrant has determined that
p.000069: the device is not subject to section 514 or 515 of the act.
p.000069: (5) For a particular device, a state- ment of the basis upon which the reg- istrant has determined
p.000069: the device is not a restricted device.
p.000069: (6) For a particular device, a state- ment of the basis for determining that the product is a device
p.000069: rather than a drug.
p.000069: (7) For a device that the owner or op- erator has manufactured for distribu- tion under a label other than
p.000069: its own, the names of all distributors for whom it has been manufactured.
p.000069: [43 FR 37999, Aug. 25, 1978, as amended at 51
p.000069: FR 33033, Sept. 18, 1986; 63 FR 5253, Feb. 2,
p.000069: 1998]
p.000069: § 807.35 Notification of registrant.
p.000069: (a) The Commissioner will provide to the official correspondent, at the ad- dress listed on the form, a
p.000069: validated copy of Form FDA–2891 or Form FDA– 2891(a) (whichever is applicable) as evi- dence of registration. A
p.000069: permanent reg- istration number will be assigned to each device establishment registered in accordance with
p.000069: these regulations.
p.000069: (b) Owners and operators of device es-
p.000069: tablishments who also manufacture or process blood or drug products at the same establishment shall also
p.000069: register with the Center for Biologics Evalua- tion and Research and Center for Drug Evaluation and
p.000069: Research, as appro- priate. Blood products shall be listed with the Center for Biologics Evalua- tion
p.000069: and Research, Food and Drug Ad-
p.000069:
p.000070: 70
p.000070: 21 CFR Ch. I (4–1–12 Edition)
p.000070: ministration, pursuant to part 607 of this chapter; drug products shall be listed with the Center for
...
Social / Linguistic Proficiency
Searching for indicator language:
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p.000071: (2) Upon request from FDA, the United States agent shall assist FDA in communications with the
p.000071: foreign es- tablishment, respond to questions con- cerning the foreign establishment’s products that are
p.000071: imported or offered for import into the United States, and assist FDA in scheduling inspections of the
p.000071: foreign establishment. If the agen- cy is unable to contact the foreign es- tablishment directly or
p.000071: expeditiously, FDA may provide information or docu- ments to the United States agent, and such an action shall be
p.000071: considered to be equivalent to providing the same infor- mation or documents to the foreign es- tablishment.
p.000071: (3) The foreign establishment or the
p.000071: United States agent shall report changes in the United States agent’s name, address, or
p.000071: phone number to FDA within 10-business days of the change.
p.000071: (c) No device may be imported or of- fered for import into the United States unless it is the subject of a
p.000071: device list- ing as required under subpart B of this part and is manufactured, prepared, propagated,
p.000071: compounded, or processed at a registered foreign establishment; however, this restriction does not
p.000071: apply to devices imported or offered for import under the investigational use provisions of part 812 of this
p.000071: chapter or to a component, part, or accessory of a device or other article of a device im- ported under
p.000071: section 801(d)(3) of the act. The establishment registration and device listing information shall
p.000071: be in the English language.
p.000071: [66 FR 59160, Nov. 27, 2001]
p.000071:
p.000071: Subpart D—Exemptions
p.000071: § 807.65 Exemptions for device estab- lishments.
p.000071: The following classes of persons are exempt from registration in accord- ance with § 807.20 under the
p.000071: provisions of section 510(g)(1), (g)(2), and (g)(3) of the act, or because the Commissioner of Food and
p.000071: Drugs has found, under section 510(g)(5) of the act, that such registration is not necessary for
p.000071: the
p.000071:
p.000071:
p.000071:
p.000071:
p.000071:
p.000071:
p.000071:
p.000071:
p.000071: § 807.81
p.000071: protection of the public health. The ex- emptions in paragraphs (d), (e), (f), and
p.000071: (i) of this section are limited to those classes of persons located in any State as defined in
p.000071: section 201(a)(1) of the act.
p.000071: (a) A manufacturer of raw materials or components to be used in the manu- facture or assembly of a device
p.000071: who would otherwise not be required to reg- ister under the provisions of this part.
p.000071: (b) A manufacturer of devices to be used solely for veterinary purposes.
p.000071: (c) A manufacturer of general pur- pose articles such as chemical reagents or laboratory equipment whose
p.000071: uses are generally known by persons trained in their use and which are not labeled or promoted for medical uses.
p.000071: (d) Licensed practitioners, including physicians, dentists, and optometrists, who manufacture or otherwise alter
p.000071: de- vices solely for use in their practice.
p.000071: (e) Pharmacies, surgical supply out- lets, or other similar retail establish- ments making final delivery
p.000071: or sale to the ultimate user. This exemption also applies to a pharmacy or other similar retail establishment
...
Social / employees
Searching for indicator employees:
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p.000076: I certify, in my capacity as (position held in company), of (company name), that I have conducted a reasonable
p.000076: search of all infor- mation known or otherwise available about the types and causes of safety or
p.000076: effective- ness problems that have been reported for the (type of device). I further certify that I am
p.000076: aware of the types of problems to which the (type of device) is susceptible and that, to the best of
p.000076: my knowledge, the following summary of the types and causes of safety or effectiveness problems about the (type of
p.000076: de- vice) is complete and accurate.
p.000076: (b) The statement in paragraph (a) of this section should be signed by the certifier, clearly identified as
p.000076: ‘‘class III certification,’’ and included at the be- ginning of the section of the premarket notification
p.000076: submission that sets forth the class III summary.
p.000076: [59 FR 64296, Dec. 14, 1994]
p.000076: § 807.95 Confidentiality of information.
p.000076: (a) The Food and Drug Administra- tion will disclose publicly whether there exists a premarket
p.000076: notification submission under this part:
p.000076: (1) Where the device is on the mar- ket, i.e., introduced or delivered for in- troduction into interstate
p.000076: commerce for commercial distribution;
p.000076: (2) Where the person submitting the premarket notification submission has disclosed, through advertising or
p.000076: any other manner, his intent to market the device to scientists, market analysts, exporters, or other individuals
p.000076: who are not employees of, or paid consultants to, the establishment and who are not in an advertising or
p.000076: law firm pursuant
p.000076:
p.000076:
p.000076:
p.000076:
p.000076:
p.000076:
p.000076:
p.000076: Food and Drug Administration, HHS § 807.95
p.000076:
p.000076:
p.000076: to commercial arrangements with ap- propriate safeguards for secrecy; or
p.000076: (3) Where the device is not on the market and the intent to market the device has not been so disclosed,
p.000076: except where the submission is subject to an exception under paragraph (b) or (c) of this section.
p.000076: (b) The Food and Drug Administra- tion will not disclose publicly the ex- istence of a premarket
p.000076: notification submission for a device that is not on the market and where the intent to market the
p.000076: device has not been dis- closed for 90 days from the date of re- ceipt of the submission, if:
p.000076: (1) The person submitting the pre- market notification submission re- quests in the submission that
p.000076: the Food and Drug Administration hold as con- fidential commercial information the intent to market the
p.000076: device and sub- mits a written certification to the Commissioner:
p.000076: (i) That the person considers his in- tent to market the device to be con- fidential commercial
p.000076: information;
p.000076: (ii) That neither the person nor, to the best of his knowledge, anyone else, has disclosed through
p.000076: advertising or any other manner, his intent to mar- ket the device to scientists, market an- alysts,
p.000076: exporters, or other individuals, except employees of, or paid consult- ants to, the establishment or
p.000076: individ- uals in an advertising or law firm pur- suant to commercial arrangements with appropriate
p.000076: safeguards for se- crecy;
p.000076: (iii) That the person will imme- diately notify the Food and Drug Ad- ministration if he
p.000076: discloses the intent to market the device to anyone, except employees of, or paid consultants to, the
p.000076: establishment or individuals in an advertising or law firm pursuant to commercial arrangements with
p.000076: appro- priate safeguards for secrecy;
p.000076: (iv) That the person has taken pre- cautions to protect the confidentiality of the intent to market the
p.000076: device; and
p.000076: (v) That the person understands that the submission to the government of false information is
p.000076: prohibited by 18
p.000076: U.S.C. 1001 and 21 U.S.C. 331(q); and
p.000076: (2) The Commissioner agrees that the intent to market the device is con- fidential commercial information.
p.000076:
p.000077: 77
p.000077:
p.000077: (c) Where the Commissioner deter- mines that the person has complied with the procedures described
p.000077: in para- graph (b) of this section with respect to a device that is not on the market and where the intent to
p.000077: market the device has not been disclosed, and the Com- missioner agrees that the intent to market
p.000077: the device is confidential com- mercial information, the Commissioner will not disclose the existence of the
p.000077: submission for 90 days from the date of its receipt by the agency. In addition, the Commissioner will continue
p.000077: not to disclose the existence of such a submis- sion for the device for an additional time when any of the
p.000077: following occurs:
p.000077: (1) The Commissioner requests in writing additional information regard- ing the device pursuant to §
p.000077: 807.87(h), in which case the Commissioner will not disclose the existence of the submis- sion until 90
...
Social / parents
Searching for indicator parent:
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p.000063: 807.40 Establishment registration and de- vice listing for foreign establishments importing or
p.000063: offering for import devices into the United States.
p.000063:
p.000063: 63
p.000063: Subpart D—Exemptions
p.000063: 807.65 Exemptions for device establish- ments.
p.000063:
p.000063: Subpart E—Premarket Notification Procedures
p.000063: 807.81 When a premarket notification sub- mission is required.
p.000063: 807.85 Exemption from premarket notifica- tion.
p.000063: 807.87 Information required in a premarket notification submission.
p.000063: 807.90 Format of a premarket notification submission.
p.000063: 807.92 Content and format of a 510(k) sum- mary.
p.000063: 807.93 Content and format of a 510(k) state- ment.
p.000063: 807.94 Format of class III certification.
p.000063: 807.95 Confidentiality of information.
p.000063: 807.97 Misbranding by reference to pre- market notification.
p.000063: 807.100 FDA action on a premarket notifica- tion.
p.000063: AUTHORITY: 21 U.S.C. 321, 331, 351, 352, 360,
p.000063: 360c, 360e, 360i, 360j, 371, 374, 381, 393; 42 U.S.C.
p.000063: 264, 271.
p.000063: SOURCE: 42 FR 42526, Aug. 23, 1977, unless
p.000063: otherwise noted.
p.000063:
p.000063: Subpart A—General Provisions
p.000063: § 807.3 Definitions.
p.000063: (a) Act means the Federal Food, Drug, and Cosmetic Act.
p.000063: (b) Commercial distribution means any distribution of a device intended for human use which is held
p.000063: or offered for sale but does not include the following:
p.000063: (1) Internal or interplant transfer of a device between establishments within the same parent, subsidiary,
p.000063: and/or af- filiate company;
p.000063: (2) Any distribution of a device in- tended for human use which has in ef- fect an approved exemption
p.000063: for inves- tigational use under section 520(g) of the act and part 812 of this chapter;
p.000063: (3) Any distribution of a device, be- fore the effective date of part 812 of this chapter, that was
p.000063: not introduced or delivered for introduction into inter- state commerce for commercial dis- tribution before
p.000063: May 28, 1976, and that is classified into class III under section 513(f) of the act: Provided, That the de-
p.000063: vice is intended solely for investiga- tional use, and under section 501(f)(2)(A) of
p.000063: the act the device is not
p.000063:
p.000063:
p.000063:
p.000063:
p.000063:
p.000063:
p.000063:
p.000063:
p.000063: § 807.3
p.000063: required to have an approved pre- market approval application as pro- vided in section 515 of
p.000063: the act; or
p.000063: (4) For foreign establishments, the distribution of any device that is nei- ther imported nor offered
p.000063: for import into the United States.
p.000063: (c) Establishment means a place of business under one management at one general physical location at
p.000063: which a device is manufactured, assembled, or otherwise processed.
p.000063: (d) Manufacture, preparation, propaga- tion, compounding, assembly, or proc- essing of a device means
p.000063: the making by chemical, physical, biological, or other procedures of any article that meets the definition
p.000063: of device in section 201(h) of the act. These terms include the following activities:
...
p.000064: susceptible and the causes of such problems.
p.000064: (r) United States agent means a person residing or maintaining a place of busi- ness in the United States whom a
p.000064: for- eign establishment designates as its agent. This definition excludes mail- boxes, answering
p.000064: machines or services, or other places where an individual
p.000064:
p.000065: 65
p.000065:
p.000065: acting as the foreign establishment’s agent is not physically present.
p.000065: (s) Wholesale distributor means any person (other than the manufacturer or the initial importer) who
p.000065: distributes a device from the original place of manu- facture to the person who makes the final delivery or
p.000065: sale of the device to the ultimate consumer or user.
p.000065: [42 FR 42526, Aug. 23, 1977, as amended at 43
p.000065: FR 37997, Aug. 25, 1978; 57 FR 18066, Apr. 28,
p.000065: 1992; 58 FR 46522, Sept. 1, 1993; 59 FR 64295,
p.000065: Dec. 14, 1994; 60 FR 63606, Dec. 11, 1995; 63 FR
p.000065: 51826, Sept. 29, 1998; 66 FR 59159, Nov. 27, 2001]
p.000065:
p.000065: Subpart B—Procedures for Device Establishments
p.000065: § 807.20 Who must register and submit a device list?
p.000065: (a) An owner or operator of an estab- lishment not exempt under section 510(g) of the act or subpart D
p.000065: of this part who is engaged in the manufac- ture, preparation, propagation, compounding,
p.000065: assembly, or processing of a device intended for human use shall register and submit listing infor-
p.000065: mation for those devices in commercial distribution, except that registration and listing information may
p.000065: be sub- mitted by the parent, subsidiary, or af- filiate company for all the domestic or foreign establishments
p.000065: under the con- trol of one of these organizations when operations are conducted at more than one
p.000065: establishment and there exists joint ownership and control among all the establishments. The term
p.000065: ‘‘device’’ includes all in vitro diagnostic prod- ucts and in vitro diagnostic biological products not
p.000065: subject to licensing under section 351 of the Public Health Service Act. An owner or operator of an estab-
p.000065: lishment located in any State as de- fined in section 201(a)(1) of the act shall register its name, places of
p.000065: business, and all establishments and list the de- vices whether or not the output of the establishments
p.000065: or any particular de- vice so listed enters interstate com- merce. The registration and listing
p.000065: re- quirements shall pertain to any person who:
p.000065: (1) Initiates or develops specifica- tions for a device that is to be manu- factured by a second party
p.000065: for commer- cial distribution by the person initi- ating specifications;
p.000065:
p.000065:
p.000065:
p.000065:
p.000065:
p.000065:
p.000065:
p.000065:
p.000065: § 807.21
p.000065: (2) Manufactures for commercial dis- tribution a device either for itself or for another person. However,
p.000065: a person who only manufactures devices accord- ing to another person’s specifications, for commercial distribution
p.000065: by the per- son initiating specifications, is not re- quired to list those devices.
p.000065: (3) Repackages or relabels a device;
p.000065: (4) Acts as an initial importer; or
...
General/Other / Relationship to Authority
Searching for indicator authority:
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p.000063: 807.22 How and where to register establish- ments and list devices.
p.000063: 807.25 Information required or requested for establishment registration and device listing.
p.000063: 807.26 Amendments to establishment reg- istration.
p.000063: 807.30 Updating device listing information.
p.000063: 807.31 Additional listing information.
p.000063: 807.35 Notification of registrant.
p.000063: 807.37 Inspection of establishment registra- tion and device listings.
p.000063: 807.39 Misbranding by reference to estab- lishment registration or to registration number.
p.000063:
p.000063: Subpart C—Registration Procedures for Foreign Device Establishments
p.000063: 807.40 Establishment registration and de- vice listing for foreign establishments importing or
p.000063: offering for import devices into the United States.
p.000063:
p.000063: 63
p.000063: Subpart D—Exemptions
p.000063: 807.65 Exemptions for device establish- ments.
p.000063:
p.000063: Subpart E—Premarket Notification Procedures
p.000063: 807.81 When a premarket notification sub- mission is required.
p.000063: 807.85 Exemption from premarket notifica- tion.
p.000063: 807.87 Information required in a premarket notification submission.
p.000063: 807.90 Format of a premarket notification submission.
p.000063: 807.92 Content and format of a 510(k) sum- mary.
p.000063: 807.93 Content and format of a 510(k) state- ment.
p.000063: 807.94 Format of class III certification.
p.000063: 807.95 Confidentiality of information.
p.000063: 807.97 Misbranding by reference to pre- market notification.
p.000063: 807.100 FDA action on a premarket notifica- tion.
p.000063: AUTHORITY: 21 U.S.C. 321, 331, 351, 352, 360,
p.000063: 360c, 360e, 360i, 360j, 371, 374, 381, 393; 42 U.S.C.
p.000063: 264, 271.
p.000063: SOURCE: 42 FR 42526, Aug. 23, 1977, unless
p.000063: otherwise noted.
p.000063:
p.000063: Subpart A—General Provisions
p.000063: § 807.3 Definitions.
p.000063: (a) Act means the Federal Food, Drug, and Cosmetic Act.
p.000063: (b) Commercial distribution means any distribution of a device intended for human use which is held
p.000063: or offered for sale but does not include the following:
p.000063: (1) Internal or interplant transfer of a device between establishments within the same parent, subsidiary,
p.000063: and/or af- filiate company;
p.000063: (2) Any distribution of a device in- tended for human use which has in ef- fect an approved exemption
p.000063: for inves- tigational use under section 520(g) of the act and part 812 of this chapter;
p.000063: (3) Any distribution of a device, be- fore the effective date of part 812 of this chapter, that was
p.000063: not introduced or delivered for introduction into inter- state commerce for commercial dis- tribution before
p.000063: May 28, 1976, and that is classified into class III under section 513(f) of the act: Provided, That the de-
p.000063: vice is intended solely for investiga- tional use, and under section 501(f)(2)(A) of
p.000063: the act the device is not
p.000063:
p.000063:
p.000063:
p.000063:
p.000063:
p.000063:
p.000063:
p.000063:
p.000063: § 807.3
p.000063: required to have an approved pre- market approval application as pro- vided in section 515 of
p.000063: the act; or
...
Orphaned Trigger Words
p.000075: notification submission for a determination of sub- stantial equivalence;
p.000075: (2) A brief discussion of the clinical tests submitted, referenced, or relied on in the premarket
p.000075: notification sub- mission for a determination of substan- tial equivalence. This discussion shall include, where
p.000075: applicable, a description of the subjects upon whom the device
p.000075:
p.000075:
p.000075:
p.000075:
p.000075:
p.000075:
p.000075:
p.000075:
p.000075: § 807.93
p.000075: was tested, a discussion of the safety or effectiveness data obtained from the testing, with specific
p.000075: reference to ad- verse effects and complications, and any other information from the clin- ical testing
p.000075: relevant to a determina- tion of substantial equivalence; and
p.000075: (3) The conclusions drawn from the nonclinical and clinical tests that dem- onstrate that the device is as
p.000075: safe, as effective, and performs as well as or better than the legally marketed de- vice identified in
p.000075: paragraph (a)(3) of this section.
p.000075: (c) The summary should be in a sepa- rate section of the submission, begin- ning on a new page and ending
p.000075: on a page not shared with any other section of the premarket notification submis- sion, and should be clearly
p.000075: identified as a ‘‘510(k) summary.’’
p.000075: (d) Any other information reasonably deemed necessary by the agency.
p.000075: [57 FR 18066, Apr. 28, 1992, as amended at 59
p.000075: FR 64295, Dec. 14, 1994]
p.000075:
p.000075: § 807.93 Content and format of a 510(k) statement.
p.000075: (a)(1) A 510(k) statement submitted as part of a premarket notification shall state as follows:
p.000075: I certify that, in my capacity as (the posi- tion held in company by person required to submit the premarket
p.000075: notification, pref- erably the official correspondent in the firm), of (company name), I will make
p.000075: avail- able all information included in this pre- market notification on safety and effective- ness
p.000075: within 30 days of request by any person if the device described in the premarket no- tification submission
p.000075: is determined to be substantially equivalent. The information I agree to make available will be a
p.000075: duplicate of the premarket notification submission, in- cluding any adverse safety and effectiveness information,
p.000075: but excluding all patient iden- tifiers, and trade secret and confidential commercial information, as
p.000075: defined in 21 CFR 20.61.
p.000075: (2) The statement in paragraph (a)(1) of this section should be signed by the certifier, made on a
p.000075: separate page of the premarket notification submission, and clearly identified as ‘‘510(k) state- ment.’’
p.000075: (b) All requests for information in- cluded in paragraph (a) of this section shall be made in writing
p.000075: to the cer- tifier, whose name will be published by FDA on the list of premarket notifica-
p.000076: 76
p.000076: 21 CFR Ch. I (4–1–12 Edition)
p.000076: tion submissions for which substantial equivalence determinations have been made.
p.000076: (c) The information provided to re- questors will be a duplicate of the pre- market notification
p.000076: submission, in- cluding any adverse information, but excluding all patient identifiers, and trade
p.000076: secret and confidential commer- cial information as defined in § 20.61 of this chapter.
p.000076: [59 FR 64295, Dec. 14, 1994]
p.000076:
...
Appendix
Indicator List
| Indicator | Vulnerability |
|---|
| age | Age |
| authority | Relationship to Authority |
| drug | Drug Usage |
| employees | employees |
| language | Linguistic Proficiency |
| nation | stateless persons |
| parent | parents |
| party | political affiliation |
| physically | Physically Disabled |
| restricted | Incarcerated |
Indicator Peers (Indicators in Same Vulnerability)
Trigger Words
capacity
protect
Applicable Type / Vulnerability / Indicator Overlay for this Input