Food and Drug Administration, HHS § 807.3 in accordance with part 20 of this chap- ter. (b) Before public disclosure of a re- port, FDA will delete from the report: (1) Any information that constitutes trade secret or confidential commer- cial or financial information under § 20.61 of this chapter; and (2) Any personnel, medical, or similar information, including the serial num- bers of implanted devices, which would constitute a clearly unwarranted inva- sion of personal privacy under § 20.63 of this chapter or 5 U.S.C. 552(b)(6); pro- vided, that except for the information under § 20.61 of this chapter or 5 U.S.C. 552(b)(4), FDA will disclose to a patient who requests a report all the informa- tion in the report concerning that pa- tient. PART 807—ESTABLISHMENT REG- ISTRATION AND DEVICE LISTING FOR MANUFACTURERS AND INI- TIAL IMPORTERS OF DEVICES Subpart A—General Provisions Sec. 807.3 Definitions. Subpart B—Procedures for Device Establishments 807.20 Who must register and submit a de- vice list? 807.21 Times for establishment registration and device listing. 807.22 How and where to register establish- ments and list devices. 807.25 Information required or requested for establishment registration and device listing. 807.26 Amendments to establishment reg- istration. 807.30 Updating device listing information. 807.31 Additional listing information. 807.35 Notification of registrant. 807.37 Inspection of establishment registra- tion and device listings. 807.39 Misbranding by reference to estab- lishment registration or to registration number. Subpart C—Registration Procedures for Foreign Device Establishments 807.40 Establishment registration and de- vice listing for foreign establishments importing or offering for import devices into the United States. 63 Subpart D—Exemptions 807.65 Exemptions for device establish- ments. Subpart E—Premarket Notification Procedures 807.81 When a premarket notification sub- mission is required. 807.85 Exemption from premarket notifica- tion. 807.87 Information required in a premarket notification submission. 807.90 Format of a premarket notification submission. 807.92 Content and format of a 510(k) sum- mary. 807.93 Content and format of a 510(k) state- ment. 807.94 Format of class III certification. 807.95 Confidentiality of information. 807.97 Misbranding by reference to pre- market notification. 807.100 FDA action on a premarket notifica- tion. AUTHORITY: 21 U.S.C. 321, 331, 351, 352, 360, 360c, 360e, 360i, 360j, 371, 374, 381, 393; 42 U.S.C. 264, 271. SOURCE: 42 FR 42526, Aug. 23, 1977, unless otherwise noted. Subpart A—General Provisions § 807.3 Definitions. (a) Act means the Federal Food, Drug, and Cosmetic Act. (b) Commercial distribution means any distribution of a device intended for human use which is held or offered for sale but does not include the following: (1) Internal or interplant transfer of a device between establishments within the same parent, subsidiary, and/or af- filiate company; (2) Any distribution of a device in- tended for human use which has in ef- fect an approved exemption for inves- tigational use under section 520(g) of the act and part 812 of this chapter; (3) Any distribution of a device, be- fore the effective date of part 812 of this chapter, that was not introduced or delivered for introduction into inter- state commerce for commercial dis- tribution before May 28, 1976, and that is classified into class III under section 513(f) of the act: Provided, That the de- vice is intended solely for investiga- tional use, and under section 501(f)(2)(A) of the act the device is not § 807.3 required to have an approved pre- market approval application as pro- vided in section 515 of the act; or (4) For foreign establishments, the distribution of any device that is nei- ther imported nor offered for import into the United States. (c) Establishment means a place of business under one management at one general physical location at which a device is manufactured, assembled, or otherwise processed. (d) Manufacture, preparation, propaga- tion, compounding, assembly, or proc- essing of a device means the making by chemical, physical, biological, or other procedures of any article that meets the definition of device in section 201(h) of the act. These terms include the following activities: (1) Repackaging or otherwise chang- ing the container, wrapper, or labeling of any device package in furtherance of the distribution of the device from the original place of manufacture to the person who makes final delivery or sale to the ultimate consumer; (2) Initial importation of devices manufactured in foreign establish- ments; or (3) Initiation of specifications for de- vices that are manufactured by a sec- ond party for subsequent commercial distribution by the person initiating specifications. (e) Official correspondent means the person designated by the owner or op- erator of an establishment as respon- sible for the following: (1) The annual registration of the es- tablishment; (2) Contact with the Food and Drug Administration for device listing; (3) Maintenance and submission of a current list of officers and directors to the Food and Drug Administration upon the request of the Commissioner; (4) The receipt of pertinent cor- respondence from the Food and Drug Administration directed to and involv- ing the owner or operator and/or any of the firm’s establishments; and (5) The annual certification of med- ical device reports required by § 804.30 of this chapter or forwarding the cer- tification form to the person des- ignated by the firm as responsible for the certification. 64 21 CFR Ch. I (4–1–12 Edition) (f) O ner or operator means the cor- poration, subsidiary, affiliated com- pany, partnership, or proprietor di- rectly responsible for the activities of the registering establishment. (g) Initial importer means any im- porter who furthers the marketing of a device from a foreign manufacturer to the person who makes the final deliv- ery or sale of the device to the ulti- mate consumer or user, but does not repackage, or otherwise change the container, wrapper, or labeling of the device or device package. (h) Any term defined in section 201 of the act shall have that meaning. (i) Restricted device means a device for which the Commissioner, by regulation under § 801.109 of this chapter or other- wise under section 520(e) of the act, has restricted sale, distribution, or use only upon the written or oral author- ization of a practitioner licensed by law to administer or use the device or upon such other conditions as the Com- missioner may prescribe. (j) Classification name means the term used by the Food and Drug Administra- tion and its classification panels to de- scribe a device or class of devices for purposes of classifying devices under section 513 of the act. (k) Representative sampling of adver- tisements means typical advertising ma- terial that gives the promotional claims made for the device. (l) Representative sampling of any other labeling means typical labeling mate- rial (excluding labels and package in- serts) that gives the promotional claims made for the device. (m) Material change includes any change or modification in the labeling or advertisements that affects the identity or safety and effectiveness of the device. These changes may include, but are not limited to, changes in the common or usual or proprietary name, declared ingredients or components, in- tended use, contraindications, warn- ings, or instructions for use. Changes that are not material may include graphic layouts, grammar, or correc- tion of typographical errors which do not change the content of the labeling, changes in lot number, and, for devices where the biological activity or known Food and Drug Administration, HHS § 807.20 composition differs with each lot pro- duced, the labeling containing the ac- tual values for each lot. (n) 510(k) summary (summary of any information respecting safety and ef- fectiveness) means a summary, sub- mitted under section 513(i) of the act, of the safety and effectiveness informa- tion contained in a premarket notifica- tion submission upon which a deter- mination of substantial equivalence can be based. Safety and effectiveness information refers to safety and effec- tiveness data and information sup- porting a finding of substantial equiva- lence, including all adverse safety and effectiveness information. (o) 510(k) statement means a state- ment, made under section 513(i) of the act, asserting that all information in a premarket notification submission re- garding safety and effectiveness will be made available within 30 days of re- quest by any person if the device de- scribed in the premarket notification submission is determined to be sub- stantially equivalent. The information to be made available will be a duplicate of the premarket notification submis- sion, including any adverse safety and effectiveness information, but exclud- ing all patient identifiers, and trade se- cret or confidential commercial infor- mation, as defined in § 20.61 of this chapter. (p) Class III certification means a cer- tification that the submitter of the 510(k) has conducted a reasonable search of all known information about the class III device and other similar, legally marketed devices. (q) Class III summary means a sum- mary of the types of safety and effec- tiveness problems associated with the type of device being compared and a ci- tation to the information upon which the summary is based. The summary must be comprehensive and describe the problems to which the type of de- vice is susceptible and the causes of such problems. (r) United States agent means a person residing or maintaining a place of busi- ness in the United States whom a for- eign establishment designates as its agent. This definition excludes mail- boxes, answering machines or services, or other places where an individual 65 acting as the foreign establishment’s agent is not physically present. (s) Wholesale distributor means any person (other than the manufacturer or the initial importer) who distributes a device from the original place of manu- facture to the person who makes the final delivery or sale of the device to the ultimate consumer or user. [42 FR 42526, Aug. 23, 1977, as amended at 43 FR 37997, Aug. 25, 1978; 57 FR 18066, Apr. 28, 1992; 58 FR 46522, Sept. 1, 1993; 59 FR 64295, Dec. 14, 1994; 60 FR 63606, Dec. 11, 1995; 63 FR 51826, Sept. 29, 1998; 66 FR 59159, Nov. 27, 2001] Subpart B—Procedures for Device Establishments § 807.20 Who must register and submit a device list? (a) An owner or operator of an estab- lishment not exempt under section 510(g) of the act or subpart D of this part who is engaged in the manufac- ture, preparation, propagation, compounding, assembly, or processing of a device intended for human use shall register and submit listing infor- mation for those devices in commercial distribution, except that registration and listing information may be sub- mitted by the parent, subsidiary, or af- filiate company for all the domestic or foreign establishments under the con- trol of one of these organizations when operations are conducted at more than one establishment and there exists joint ownership and control among all the establishments. The term ‘‘device’’ includes all in vitro diagnostic prod- ucts and in vitro diagnostic biological products not subject to licensing under section 351 of the Public Health Service Act. An owner or operator of an estab- lishment located in any State as de- fined in section 201(a)(1) of the act shall register its name, places of business, and all establishments and list the de- vices whether or not the output of the establishments or any particular de- vice so listed enters interstate com- merce. The registration and listing re- quirements shall pertain to any person who: (1) Initiates or develops specifica- tions for a device that is to be manu- factured by a second party for commer- cial distribution by the person initi- ating specifications; § 807.21 (2) Manufactures for commercial dis- tribution a device either for itself or for another person. However, a person who only manufactures devices accord- ing to another person’s specifications, for commercial distribution by the per- son initiating specifications, is not re- quired to list those devices. (3) Repackages or relabels a device; (4) Acts as an initial importer; or (5) Manufactures components or ac- cessories which are ready to be used for any intended health-related purpose and are packaged or labeled for com- mercial distribution for such health-re- lated purpose, e.g., blood filters, hemo- dialysis tubing, or devices which of ne- cessity must be further processed by a licensed practitioner or other qualified person to meet the needs of a par- ticular patient, e.g., a manufacturer of ophthalmic lens blanks. (b) No registration or listing fee is re- quired. Registration or listing does not constitute an admission or agreement or determination that a product is a 21 CFR Ch. I (4–1–12 Edition) ditional listing information require- ments of § 807.31 remain applicable. [42 FR 42526, Aug. 23, 1977, as amended at 43 FR 37997, Aug. 25, 1978; 58 FR 46522, Sept. 1, 1993; 60 FR 63606, Dec. 11, 1995; 63 FR 51826, Sept. 29, 1998; 66 FR 5466, Jan. 19, 2001; 66 FR 59160, Nov. 27, 2001] § 807.21 Times for establishment reg- istration and device listing. (a) An owner or operator of an estab- lishment who has not previously en- tered into an operation defined in § 807.20 shall register within 30 days after entering into such an operation and submit device listing information at that time. An owner or operator of an establishment shall update its reg- istration information annually within 30 days after receiving registration forms from FDA. FDA will mail form FDA-2891a to the owners or operators of registered establishments according to a schedule based on the first letter of the name of the owner or operator. The schedule is as follows: device within the meaning of section 201(h) of the act. (c) Registration and listing require- ments shall not pertain to any person who: (1) Manufacturers devices for another First letter of owner or oper- ator name A, B, C, D, E .......................... F, G, H, I, J, K, L, M .............. N, O, P, Q, R ......................... S, T, U, V, W, X, Y, Z ........... Date FDA will mail forms March. June. August. November. party who both initiated the specifica- tions and commercially distributes the device; (2) Sterilizes devices on a contract basis for other registered facilities who commercially distribute the devices. (3) Acts as a wholesale distributor, as defined in § 807.3(s), and who does not manufacture, repackage, process, or relabel a device. (d) Owners and operators of establish- ments or persons engaged in the recov- ery, screening, testing, processing, storage, or distribution of human cells, tissues, and cellular and tissue-based products, as defined in § 1271.3(d) of this chapter, that are regulated under the Federal Food, Drug, and Cosmetic Act must register and list those human cells, tissues, and cellular and tissue- based products with the Center for Bio- logics Evaluation and Research on Form FDA 3356 following the proce- dures set out in subpart B of part 1271 of this chapter, instead of the proce- dures for registration and listing con- tained in this part, except that the ad- 66 (b) Owners or operators of all reg- istered establishments shall update their device listing information every June and December or, at their discre- tion, at the time the change occurs. [58 FR 46522, Sept. 1, 1993] § 807.22 How and where to register es- tablishments and list devices. (a) The first registration of a device establishment shall be on Form FDA– 2891 (Initial Registration of Device Es- tablishment). Forms are available upon request from the Food and Drug Ad- ministration, Center for Devices and Radiological Health, Office of Compli- ance, 10903 New Hampshire Ave., Bldg. 66, rm. 3521, Silver Spring, MD 20993– 0002, or from Food and Drug Adminis- tration district offices. Subsequent an- nual registration shall be accomplished on Form FDA–2891a (Annual Registra- tion of Device Establishment), which will be furnished by FDA to establish- ments whose registration for that year was validated under § 807.35(a). The Food and Drug Administration, HHS § 807.25 forms will be mailed to the owner or operators of all establishments by the official correspondent in accordance with the schedule as described in § 807.21(a). The completed form shall be mailed to the address designated in this paragraph 30 days after receipt from FDA. (b) The initial listing of devices and subsequent June and December updatings shall be on form FDA–2892 (Medical Device Listing). Forms are obtainable upon request as described in paragraph (a) of this section. A sepa- rate form FDA–2892 shall be submitted for each device or device class listed with the Food and Drug Administra- tion. Devices having variations in physical characteristics such as size, package, shape, color, or composition should be considered to be one device: Provided, The variation does not change the function or intended use of the device. In lieu of form FDA–2892, tapes for computer input or hard copy computer output may by submitted if equivalent in all elements of informa- tion as specified in form FDA–2892. All formats proposed for use in lieu of form FDA–2892 require initial review and ap- proval by the Food and Drug Adminis- tration.’’ (c) The listing obligations of the ini- tial importer are satisfied as follows: (1) The initial importer is not re- quired to submit a form FDA-2892 for those devices for which such initial im- porter did not initiate or develop the specifications for the device or repack- age or relabel the device. However, the initial importer shall submit, for each device, the name and address of the manufacturer. Initial importers shall also be prepared to submit, when re- quested by FDA, the proprietary name, if any, and the common or usual name of each device for which they are the initial importers; and (2) The initial importer shall update the information required by paragraphs (c)(1) of this section at the intervals specified in § 807.30. [43 FR 37997, Aug. 25, 1978, as amended at 58 FR 46522, Sept. 1, 1993; 60 FR 63606, Dec. 11, 1995; 63 FR 51826, Sept. 29, 1998; 69 FR 11311, Mar. 10, 2004; 69 FR 18473, Apr. 8, 2004; 69 FR 25489, May 7, 2004; 75 FR 20914, Apr. 22, 2010] 67 § 807.25 Information required or re- quested for establishment registra- tion and device listing. (a) Form FDA–2891 and Form FDA– 2891(a) are the approved forms for ini- tially providing the information re- quired by the act and for providing an- nual registration, respectively. The re- quired information includes the name and street address of the device estab- lishment, including post office code, all trade names used by the establishment, and the business trading name of the owner or operator of such establish- ment. (b) The owner or operator shall iden- tify the device activities of the estab- lishment such as manufacturing, re- packaging, or distributing devices. (c) Each owner or operator is re- quired to maintain a listing of all offi- cers, directors, and partners for each establishment he registers and to fur- nish this information to the Food and Drug Administration upon request. (d) Each owner or operator shall pro- vide the name of an official cor- respondent who will serve as a point of contact between the Food and Drug Administration and the establishment for matters relating to the registration of device establishments and the list- ing of device products. All future cor- respondence relating to registration, including requests for the names of partners, officers, and directors, will be directed to this official correspondent. In the event no person is designated by the owner or operator, the owner or op- erator of the establishment will be the official correspondent. (e) The designation of an official cor- respondent does not in any manner af- fect the liability of the owner or oper- ator of the establishment or any other individual under section 301(p) or any other provision of the act. (f) Form FD–2892 is the approved form for providing the device listing information required by the act. This required information includes the fol- lowing: (1) The identification by classifica- tion name and number, proprietary name, and common or usual name of each device being manufactured, pre- pared, propagated, compounded, or processed for commercial distribution that has not been included in any list § 807.26 of devices previously submitted on form FDA–2892. (2) The Code of Federal Regulations citation for any applicable standard for the device under section 514 of the act or section 358 of the Public Health Service Act. (3) The assigned Food and Drug Ad- ministration number of the approved application for each device listed that is subject to section 505 or 515 of the act. (4) The name, registration number, and establishment type of every domes- tic or foreign device establishment under joint ownership and control of the owner or operator at which the de- vice is manufactured, repackaged, or relabeled. (5) Whether the device, as labeled, is intended for distribution to and use by the general public. (6) Other general information re- quested on form FDA–2892, i.e., (i) If the submission refers to a pre- viously listed device, as in the case of an update, the document number from the initial listing document for the de- vice, (ii) The reason for submission, (iii) The date on which the reason for submission occurred, (iv) The date that the form FDA–2892 was completed, (v) The owner’s or operator’s name and identification number. (7) Labeling or other descriptive in- formation (e.g., specification sheets or catalogs) adequate to describe the in- tended use of a device when the owner or operator is unable to find an appro- priate FDA classification name for the device. [42 FR 42526, Aug. 23, 1977, as amended at 43 FR 37998, Aug. 25, 1978; 58 FR 46523, Sept. 1, 1993; 64 FR 404, Jan. 5, 1999; 66 FR 59160, Nov. 27, 2001; 69 FR 11312, Mar. 10, 2004] § 807.26 Amendments to establishment registration. Changes in individual ownership, cor- porate or partnership structure, or lo- cation of an operation defined in § 807.3(c) shall be submitted on Form FDA–2891(a) at the time of annual reg- istration, or by letter if the changes occur at other times. This information shall be submitted within 30 days of such changes. Changes in the names of 68 21 CFR Ch. I (4–1–12 Edition) officers and/or directors of the corpora- tion(s) shall be filed with the establish- ment’s official correspondent and shall be provided to the Food and Drug Ad- ministration upon receipt of a written request for this information. [69 FR 11312, Mar. 10, 2004] § 807.30 Updating device listing infor- mation. (a) Form FDA–2892 shall be used to update device listing information. The preprinted original document number of each form FDA–2892 on which the de- vice was initially listed shall appear on the form subsequently used to update the listing information for the device and on any correspondence related to the device. (b) An owner or operator shall update the device listing information during each June and December or, at its dis- cretion, at the time the change occurs. Conditions that require updating and information to be submitted for each of these updates are as follows: (1) If an owner or operator introduces into commercial distribution a device identified with a classification name not currently listed by the owner or operator, then the owner or operator must submit form FDA–2892 containing all the information required by § 807.25(f). (2) If an owner or operator discon- tinues commercial distribution of all devices in the same device class, i.e., with the same classification name, the owner or operator must submit form FDA–2892 containing the original docu- ment number of the form FDA–2892 on which the device class was initially listed, the reason for submission, the date of discontinuance, the owner or operator’s name and identification number, the classification name and number, the proprietary name, and the common or usual name of the discon- tinued device. (3) If commercial distribution of a discontinued device identified on a form FDA–2892 filed under paragraph (b)(2) of this section is resumed, the owner or operator must submit on form FDA–2892 a notice of resumption con- taining: the original document number of the form initially used to list that device class, the reason for submission, Food and Drug Administration, HHS § 807.31 date of resumption, and all other infor- mation required by § 807.25(f). (4) If one or more classification names for a previously listed device with multiple classification names has been added or deleted, the owner or op- erator must supply the original docu- ment number from the form FDA–2892 on which the device was initially listed and a supplemental sheet identifying the names of any new or deleted classi- fication names. (5) Other changes to information on form FDA–2892 will be updated as fol- lows: (i) Whenever a change occurs only in the owner or operator name or number, e.g., whenever one company’s device line is purchased by another owner or operator, it will not be necessary to supply a separate form FDA–2892 for each device. In such cases, the new owner or operator must follow the pro- cedures in § 807.26 and submit a letter informing the Food and Drug Adminis- tration of the original document num- ber from form FDA–2892 on which each device was initially listed for those de- vices affected by the change in owner- ship. (ii) The owner or operator must also submit update information whenever establishment registration numbers, establishment names, and/or activities are added to or deleted from form FDA 2892. The owner or operator must sup- ply the original document number from the form FDA–2892 on which the device was initially listed, the reason for sub- mission, and all other information re- quired by § 807.25(f). (6) Updating is not required if the above information has not changed since the previously submitted list. Also, updating is not required if changes occur in proprietary names, in common or usual names, or to supple- mental lists of unclassified components or accessories. [69 FR 11312, Mar. 10, 2004] § 807.31 Additional listing information. (a) Each owner or operator shall maintain a historical file containing the labeling and advertisements in use on the date of initial listing, and in use after October 10, 1978, but before the date of initial listing, as follows: 69 (1) For each device subject to section 514 or 515 of the act that is not a re- stricted device, a copy of all labeling for the device; (2) For each restricted device, a copy of all labeling and advertisements for the device; (3) For each device that is neither re- stricted nor subject to section 514 or 515 of the act, a copy of all labels, package inserts, and a representative sampling of any other labeling. (b) In addition to the requirements set forth in paragraph (a) of this sec- tion, each owner or operator shall maintain in the historical file any la- beling or advertisements in which a material change has been made any- time after initial listing. (c) Each owner or operator may dis- card labeling and advertisements from the historical file 3 years after the date of the last shipment of a discontinued device by an owner or operator. (d) Location of the file: (1) Currently existing systems for maintenance of labeling and adver- tising may be used for the purpose of maintaining the historical file as long as the information included in the sys- tems fulfills the requirements of this section, but only if the labeling and ad- vertisements are retrievable in a time- ly manner. (2) The contents of the historical file may be physically located in more than one place in the establishment or in more than one establishment provided there exists joint ownership and con- trol among all the establishments maintaining the historical file. If no joint ownership and control exists, the registered establishment must provide the Food and Drug Administration with a letter authorizing the establish- ment outside its control to maintain the historical file. (3) A copy of the certification and disclosure statements as required by part 54 of this chapter shall be retained and physically located at the establish- ment maintaining the historical file. (e) Each owner or operator shall be prepared to submit to the Food and Drug Administration, only upon spe- cific request, the following informa- tion: (1) For a device subject to section 514 or 515 of the act that is not a restricted § 807.35 device, a copy of all labeling for the de- vice. (2) For a device that is a restricted device, a copy of all labeling for the de- vice, a representative sampling of ad- vertisements for the device, and for good cause, a copy of all advertise- ments for a particular device. A re- quest for all advertisements will, where feasible, be accompanied by an expla- nation of the basis for such request. (3) For a device that is neither a re- stricted device, nor subject to section 514 of 515 of the act, the label and pack- age insert for the device and a rep- resentative sampling of any other la- beling for the device. (4) For a particular device, a state- ment of the basis upon which the reg- istrant has determined that the device is not subject to section 514 or 515 of the act. (5) For a particular device, a state- ment of the basis upon which the reg- istrant has determined the device is not a restricted device. (6) For a particular device, a state- ment of the basis for determining that the product is a device rather than a drug. (7) For a device that the owner or op- erator has manufactured for distribu- tion under a label other than its own, the names of all distributors for whom it has been manufactured. [43 FR 37999, Aug. 25, 1978, as amended at 51 FR 33033, Sept. 18, 1986; 63 FR 5253, Feb. 2, 1998] § 807.35 Notification of registrant. (a) The Commissioner will provide to the official correspondent, at the ad- dress listed on the form, a validated copy of Form FDA–2891 or Form FDA– 2891(a) (whichever is applicable) as evi- dence of registration. A permanent reg- istration number will be assigned to each device establishment registered in accordance with these regulations. (b) Owners and operators of device es- tablishments who also manufacture or process blood or drug products at the same establishment shall also register with the Center for Biologics Evalua- tion and Research and Center for Drug Evaluation and Research, as appro- priate. Blood products shall be listed with the Center for Biologics Evalua- tion and Research, Food and Drug Ad- 70 21 CFR Ch. I (4–1–12 Edition) ministration, pursuant to part 607 of this chapter; drug products shall be listed with the Center for Drug Evalua- tion and Research, Food and Drug Ad- ministration, pursuant to part 207 of this chapter. (c) Although establishment registra- tion and device listing are required to engage in the device activities de- scribed in § 807.20, validation of reg- istration and the assignment of a de- vice listing number in itself does not establish that the holder of the reg- istration is legally qualified to deal in such devices and does not represent a determination by the Food and Drug Administration as to the status of any device. [69 FR 11312, Mar. 10, 2004] § 807.37 Inspection of establishment registration and device listings. (a) A copy of the forms FDA–2891 and FDA–2891a filed by the registrant will be available for inspection in accord- ance with section 510(f) of the act, at the Food and Drug Administration, Center for Devices and Radiological Health, Office of Compliance, 10903 New Hampshire Ave., Bldg. 66, rm. 3521, Sil- ver Spring, MD 20993–0002. In addition, there will be available for inspection at each of the Food and Drug Administra- tion district offices the same informa- tion for firms within the geographical area of such district office. Upon re- quest, verification of registration num- ber or location of a registered estab- lishment will be provided. (b)(1) The following information filed under the device listing requirements will be available for public disclosure: (i) Each form FDA–2892 submitted; (ii) All labels submitted; (iii) All labeling submitted; (iv) All advertisements submitted; (v) All data or information that has already become a matter of public knowledge. (2) Requests for device listing infor- mation identified in paragraph (b)(1) of this section should be directed to the Food and Drug Administration, Center for Devices and Radiological Health, Office of Compliance, 10903 New Hamp- shire Ave., Bldg. 66, rm. 3521, Silver Spring, MD 20993–0002. (3) Requests for device listing infor- mation not identified in paragraph Food and Drug Administration, HHS § 807.65 (b)(1) of this section shall be submitted and handled in accordance with part 20 of this chapter. [69 FR 11313, Mar. 10, 2004, as amended at 75 FR 20914, Apr. 22, 2010] § 807.39 Misbranding by reference to establishment registration or to registration number. Registration of a device establish- ment or assignment of a registration number does not in any way denote ap- proval of the establishment or its prod- ucts. Any representation that creates an impression of official approval be- cause of registration or possession of a registration number is misleading and constitutes misbranding. Subpart C—Registration Proce- dures for Foreign Device Es- tablishments § 807.40 Establishment registration and device listing for foreign estab- lishments importing or offering for import devices into the United States. (a) Any establishment within any foreign country engaged in the manu- facture, preparation, propagation, compounding, or processing of a device that is imported or offered for import into the United States shall register and list such devices in conformance with the requirements in subpart B of this part unless the device enters a for- eign trade zone and is re-exported from that foreign trade zone without having entered U. S. commerce. The official correspondent for the foreign establish- ment shall facilitate communication between the foreign establishment’s management and representatives of the Food and Drug Administration for matters relating to the registration of device establishments and the listing of device products. (b) Each foreign establishment re- quired to register under paragraph (a) of this section shall submit the name, address, and phone number of its United States agent as part of its ini- tial and updated registration informa- tion in accordance with subpart B of this part. Each foreign establishment shall designate only one United States agent and may designate the United 71 States agent to act as its official cor- respondent. (1) The United States agent shall re- side or maintain a place of business in the United States. (2) Upon request from FDA, the United States agent shall assist FDA in communications with the foreign es- tablishment, respond to questions con- cerning the foreign establishment’s products that are imported or offered for import into the United States, and assist FDA in scheduling inspections of the foreign establishment. If the agen- cy is unable to contact the foreign es- tablishment directly or expeditiously, FDA may provide information or docu- ments to the United States agent, and such an action shall be considered to be equivalent to providing the same infor- mation or documents to the foreign es- tablishment. (3) The foreign establishment or the United States agent shall report changes in the United States agent’s name, address, or phone number to FDA within 10-business days of the change. (c) No device may be imported or of- fered for import into the United States unless it is the subject of a device list- ing as required under subpart B of this part and is manufactured, prepared, propagated, compounded, or processed at a registered foreign establishment; however, this restriction does not apply to devices imported or offered for import under the investigational use provisions of part 812 of this chapter or to a component, part, or accessory of a device or other article of a device im- ported under section 801(d)(3) of the act. The establishment registration and device listing information shall be in the English language. [66 FR 59160, Nov. 27, 2001] Subpart D—Exemptions § 807.65 Exemptions for device estab- lishments. The following classes of persons are exempt from registration in accord- ance with § 807.20 under the provisions of section 510(g)(1), (g)(2), and (g)(3) of the act, or because the Commissioner of Food and Drugs has found, under section 510(g)(5) of the act, that such registration is not necessary for the § 807.81 protection of the public health. The ex- emptions in paragraphs (d), (e), (f), and (i) of this section are limited to those classes of persons located in any State as defined in section 201(a)(1) of the act. (a) A manufacturer of raw materials or components to be used in the manu- facture or assembly of a device who would otherwise not be required to reg- ister under the provisions of this part. (b) A manufacturer of devices to be used solely for veterinary purposes. (c) A manufacturer of general pur- pose articles such as chemical reagents or laboratory equipment whose uses are generally known by persons trained in their use and which are not labeled or promoted for medical uses. (d) Licensed practitioners, including physicians, dentists, and optometrists, who manufacture or otherwise alter de- vices solely for use in their practice. (e) Pharmacies, surgical supply out- lets, or other similar retail establish- ments making final delivery or sale to the ultimate user. This exemption also applies to a pharmacy or other similar retail establishment that purchases a device for subsequent distribution under its own name, e.g., a properly la- beled health aid such as an elastic ban- dage or crutch, indicating ‘‘distributed by’’ or ‘‘manufactured for’’ followed by the name of the pharmacy. (f) Persons who manufacture, pre- pare, propagate, compound, or process devices solely for use in research, teaching, or analysis and do not intro- duce such devices into commercial dis- tribution. (g) [Reserved] (h) Carriers by reason of their re- ceipt, carriage, holding or delivery of devices in the usual course of business as carriers. (i) Persons who dispense devices to the ultimate consumer or whose major responsibility is to render a service necessary to provide the consumer (i.e., patient, physician, layman, etc.) with a device or the benefits to be derived from the use of a device; for example, a hearing aid dispenser, optician, clinical laboratory, assembler of diagnostic x- ray systems, and personnel from a hos- pital, clinic, dental laboratory, orthotic or prosthetic retail facility, whose primary responsibility to the ul- 72 21 CFR Ch. I (4–1–12 Edition) timate consumer is to dispense or pro- vide a service through the use of a pre- viously manufactured device. [42 FR 42526, Aug. 23, 1977, as amended at 58 FR 46523, Sept. 1, 1993; 61 FR 44615, Aug. 28, 1996; 65 FR 17136, Mar. 31, 2000; 66 FR 59160, Nov. 27, 2001] Subpart E—Premarket Notification Procedures § 807.81 When a premarket notification submission is required. (a) Except as provided in paragraph (b) of this section, each person who is required to register his establishment pursuant to § 807.20 must submit a pre- market notification submission to the Food and Drug Administration at least 90 days before he proposes to begin the introduction or delivery for introduc- tion into interstate commerce for com- mercial distribution of a device in- tended for human use which meets any of the following criteria: (1) The device is being introduced into commercial distribution for the first time; that is, the device is not of the same type as, or is not substan- tially equivalent to, (i) a device in commercial distribution before May 28, 1976, or (ii) a device introduced for commercial distribution after May 28, 1976, that has subsequently been reclas- sified into class I or II. (2) The device is being introduced into commercial distribution for the first time by a person required to reg- ister, whether or not the device meets the criteria in paragraph (a)(1) of this section. (3) The device is one that the person currently has in commercial distribu- tion or is reintroducing into commer- cial distribution, but that is about to be significantly changed or modified in design, components, method of manu- facture, or intended use. The following constitute significant changes or modi- fications that require a premarket no- tification: (i) A change or modification in the device that could significantly affect the safety or effectiveness of the de- vice, e.g., a significant change or modi- fication in design, material, chemical composition, energy source, or manu- facturing process. Food and Drug Administration, HHS § 807.87 (ii) A major change or modification in the intended use of the device. (b)(1) A premarket notification under this subpart is not required for a device for which a premarket approval appli- cation under section 515 of the act, or for which a petition to reclassify under section 513(f)(2) of the act, is pending before the Food and Drug Administra- tion. (2) The appropriate FDA Center Di- rector may determine that the submis- sion and grant of a written request for an exception or alternative under § 801.128 or § 809.11 of this chapter satis- fies the requirement in paragraph (a)(3) of this section. (c) In addition to complying with the requirements of this part, owners or operators of device establishments that manufacture radiation-emitting elec- tronic products, as defined in § 1000.3 of this chapter, shall comply with the re- porting requirements of part 1002 of this chapter. [42 FR 42526, Aug. 23, 1977, as amended at 72 FR 73601, Dec. 28, 2007] § 807.85 Exemption from premarket notification. (a) A device is exempt from the pre- market notification requirements of this subpart if the device intended for introduction into commercial distribu- tion is not generally available in fin- ished form for purchase and is not of- fered through labeling or advertising by the manufacturer, importer, or dis- tributor thereof for commercial dis- tribution, and the device meets one of the following conditions: (1) It is intended for use by a patient named in the order of the physician or dentist (or other specially qualified person); or (2) It is intended solely for use by a physician or dentist (or other specially qualified person) and is not generally available to, or generally used by, other physicians or dentists (or other specially qualified persons). (b) A distributor who places a device into commercial distribution for the first time under his own name and a re- packager who places his own name on a device and does not change any other labeling or otherwise affect the device shall be exempted from the premarket 73 notification requirements of this sub- part if: (1) The device was in commercial dis- tribution before May 28, 1976; or (2) A premarket notification submis- sion was filed by another person. § 807.87 Information required in a pre- market notification submission. Each premarket notification submis- sion shall contain the following infor- mation: (a) The device name, including both the trade or proprietary name and the common or usual name or classifica- tion name of the device. (b) The establishment registration number, if applicable, of the owner or operator submitting the premarket no- tification submission. (c) The class in which the device has been put under section 513 of the act and, if known, its appropriate panel; or, if the owner or operator determines that the device has not been classified under such section, a statement of that determination and the basis for the person’s determination that the device is not so classified. (d) Action taken by the person re- quired to register to comply with the requirements of the act under section 514 for performance standards. (e) Proposed labels, labeling, and ad- vertisements sufficient to describe the device, its intended use, and the direc- tions for its use. Where applicable, pho- tographs or engineering drawings should be supplied. (f) A statement indicating the device is similar to and/or different from other products of comparable type in commercial distribution, accompanied by data to support the statement. This information may include an identifica- tion of similar products, materials, de- sign considerations, energy expected to be used or delivered by the device, and a description of the operational prin- ciples of the device. (g) Where a person required to reg- ister intends to introduce into com- mercial distribution a device that has undergone a significant change or modification that could significantly affect the safety or effectiveness of the device, or the device is to be marketed for a new or different indication for § 807.90 use, the premarket notification sub- mission must include appropriate sup- porting data to show that the manufac- turer has considered what con- sequences and effects the change or modification or new use might have on the safety and effectiveness of the de- vice. (h) A 510(k) summary as described in § 807.92 or a 510(k) statement as de- scribed in § 807.93. (i) A financial certification or disclo- sure statement or both, as required by part 54 of this chapter. (j) For submissions claiming substan- tial equivalence to a device which has been classified into class III under sec- tion 513(b) of the act: (1) Which was introduced or delivered for introduction into interstate com- merce for commercial distribution be- fore December 1, 1990; and (2) For which no final regulation re- quiring premarket approval has been issued under section 515(b) of the act, a summary of the types of safety and ef- fectiveness problems associated with the type of devices being compared and a citation to the information upon which the summary is based (class III summary). The 510(k) submitter shall also certify that a reasonable search of all information known or otherwise available about the class III device and other similar legally marketed devices has been conducted (class III certifi- cation), as described in § 807.94. This in- formation does not refer to informa- tion that already has been submitted to the Food and Drug Administration (FDA) under section 519 of the act. FDA may require the submission of the adverse safety and effectiveness data described in the class III summary or citation. (k) A statement that the submitter believes, to the best of his or her knowledge, that all data and informa- tion submitted in the premarket notifi- cation are truthful and accurate and that no material fact has been omitted. (l) Any additional information re- garding the device requested by the Commissioner that is necessary for the Commissioner to make a finding as to whether or not the device is substan- tially equivalent to a device in com- mercial distribution. A request for ad- ditional information will advise the 74 21 CFR Ch. I (4–1–12 Edition) owner or operator that there is insuffi- cient information contained in the original premarket notification sub- mission for the Commissioner to make this determination and that the owner or operator may either submit the re- quested data or a new premarket noti- fication containing the requested infor- mation at least 90 days before the owner or operator intends to market the device, or submit a premarket ap- proval application in accordance with section 515 of the act. If the additional information is not submitted within 30 days following the date of the request, the Commissioner will consider the premarket notification to be with- drawn. (Information collection requirements in this section were approved by the Office of Man- agement and Budget (OMB) and assigned OMB control number 0910–0281) [42 FR 42526, Aug 23, 1977, as amended at 57 FR 18066, Apr. 28, 1992; 59 FR 64295, Dec. 14, 1994; 63 FR 5253, Feb. 2, 1998] § 807.90 Format of a premarket notifi- cation submission. Each premarket notification submis- sion pursuant to this part shall be sub- mitted in accordance with this section. Each submission shall: (a)(1) For devices regulated by the Center for Devices and Radiological Health, be addressed to the Food and Drug Administration, Center for De- vices and Radiological Health, Docu- ment Mail Center, 10903 New Hamp- shire Ave., Bldg. 66, rm. G609, Silver Spring, MD 20993–0002. (2) For devices regulated by the Cen- ter for Biologics Evaluation and Re- search, be addressed to the Document Control Center (HFM–99), Center for Biologics Evaluation and Research, Food and Drug Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852–1448; or for devices regulated by the Center for Drug Evaluation and Research, be addressed to the Central Document Room, Center for Drug Eval- uation and Research, Food and Drug Administration, 5901–B Ammendale Rd., Beltsville, MD 20705–1266. Informa- tion about devices regulated by the Center for Biologics Evaluation and Research is available at http:// .fda.gov/cber/dap/devlst.htm on the Internet. Food and Drug Administration, HHS § 807.92 (3) All inquiries regarding a pre- market notification submission should be in writing and sent to one of the ad- dresses above. (b) Be bound into a volume or vol- umes, where necessary. (c) Be submitted in duplicate on standard size paper, including the original and two copies of the cover letter. (d) Be submitted separately for each product the manufacturer intends to market. (e) Designated ‘‘510(k) Notification’’ in the cover letter. [42 FR 42526, Aug. 23, 1977, as amended at 53 FR 11252, Apr. 6, 1988; 55 FR 11169, Mar. 27, 1990; 65 FR 17137, Mar. 31, 2000; 70 FR 14986, Mar. 24, 2005; 75 FR 20915, Apr. 22, 2010] § 807.92 Content and format of a 510(k) summary. (a) A 510(k) summary shall be in suf- ficient detail to provide an under- standing of the basis for a determina- tion of substantial equivalence. FDA will accept summaries as well as amendments thereto until such time as FDA issues a determination of substan- tial equivalence. All 510(k) summaries shall contain the following informa- tion: (1) The submitter’s name, address, telephone number, a contact person, and the date the summary was pre- pared; (2) The name of the device, including the trade or proprietary name if appli- cable, the common or usual name, and the classification name, if known; (3) An identification of the legally marketed device to which the sub- mitter claims equivalence. A legally marketed device to which a new device may be compared for a determination regarding substantial equivalence is a device that was legally marketed prior to May 28, 1976, or a device which has been reclassified from class III to class II or I (the predicate), or a device which has been found to be substan- tially equivalent through the 510(k) premarket notification process; (4) A description of the device that is the subject of the premarket notifica- tion submission, such as might be found in the labeling or promotional material for the device, including an explanation of how the device func- 75 tions, the scientific concepts that form the basis for the device, and the signifi- cant physical and performance charac- teristics of the device, such as device design, material used, and physical properties; (5) A statement of the intended use of the device that is the subject of the premarket notification submission, in- cluding a general description of the diseases or conditions that the device will diagnose, treat, prevent, cure, or mitigate, including a description, where appropriate, of the patient popu- lation for which the device is intended. If the indication statements are dif- ferent from those of the legally mar- keted device identified in paragraph (a)(3) of this section, the 510(k) sum- mary shall contain an explanation as to why the differences are not critical to the intended therapeutic, diag- nostic, prosthetic, or surgical use of the device, and why the differences do not affect the safety and effectiveness of the device when used as labeled; and (6) If the device has the same techno- logical characteristics (i.e., design, ma- terial, chemical composition, energy source) as the predicate device identi- fied in paragraph (a)(3) of this section, a summary of the technological char- acteristics of the new device in com- parison to those of the predicate de- vice. If the device has different techno- logical characteristics from the predi- cate device, a summary of how the technological characteristics of the de- vice compare to a legally marketed de- vice identified in paragraph (a)(3) of this section. (b) 510(k) summaries for those pre- market submissions in which a deter- mination of substantial equivalence is also based on an assessment of per- formance data shall contain the fol- lowing information: (1) A brief discussion of the nonclin- ical tests submitted, referenced, or re- lied on in the premarket notification submission for a determination of sub- stantial equivalence; (2) A brief discussion of the clinical tests submitted, referenced, or relied on in the premarket notification sub- mission for a determination of substan- tial equivalence. This discussion shall include, where applicable, a description of the subjects upon whom the device § 807.93 was tested, a discussion of the safety or effectiveness data obtained from the testing, with specific reference to ad- verse effects and complications, and any other information from the clin- ical testing relevant to a determina- tion of substantial equivalence; and (3) The conclusions drawn from the nonclinical and clinical tests that dem- onstrate that the device is as safe, as effective, and performs as well as or better than the legally marketed de- vice identified in paragraph (a)(3) of this section. (c) The summary should be in a sepa- rate section of the submission, begin- ning on a new page and ending on a page not shared with any other section of the premarket notification submis- sion, and should be clearly identified as a ‘‘510(k) summary.’’ (d) Any other information reasonably deemed necessary by the agency. [57 FR 18066, Apr. 28, 1992, as amended at 59 FR 64295, Dec. 14, 1994] § 807.93 Content and format of a 510(k) statement. (a)(1) A 510(k) statement submitted as part of a premarket notification shall state as follows: I certify that, in my capacity as (the posi- tion held in company by person required to submit the premarket notification, pref- erably the official correspondent in the firm), of (company name), I will make avail- able all information included in this pre- market notification on safety and effective- ness within 30 days of request by any person if the device described in the premarket no- tification submission is determined to be substantially equivalent. The information I agree to make available will be a duplicate of the premarket notification submission, in- cluding any adverse safety and effectiveness information, but excluding all patient iden- tifiers, and trade secret and confidential commercial information, as defined in 21 CFR 20.61. (2) The statement in paragraph (a)(1) of this section should be signed by the certifier, made on a separate page of the premarket notification submission, and clearly identified as ‘‘510(k) state- ment.’’ (b) All requests for information in- cluded in paragraph (a) of this section shall be made in writing to the cer- tifier, whose name will be published by FDA on the list of premarket notifica- 76 21 CFR Ch. I (4–1–12 Edition) tion submissions for which substantial equivalence determinations have been made. (c) The information provided to re- questors will be a duplicate of the pre- market notification submission, in- cluding any adverse information, but excluding all patient identifiers, and trade secret and confidential commer- cial information as defined in § 20.61 of this chapter. [59 FR 64295, Dec. 14, 1994] § 807.94 Format of a class III certifi- cation. (a) A class III certification submitted as part of a premarket notification shall state as follows: I certify, in my capacity as (position held in company), of (company name), that I have conducted a reasonable search of all infor- mation known or otherwise available about the types and causes of safety or effective- ness problems that have been reported for the (type of device). I further certify that I am aware of the types of problems to which the (type of device) is susceptible and that, to the best of my knowledge, the following summary of the types and causes of safety or effectiveness problems about the (type of de- vice) is complete and accurate. (b) The statement in paragraph (a) of this section should be signed by the certifier, clearly identified as ‘‘class III certification,’’ and included at the be- ginning of the section of the premarket notification submission that sets forth the class III summary. [59 FR 64296, Dec. 14, 1994] § 807.95 Confidentiality of information. (a) The Food and Drug Administra- tion will disclose publicly whether there exists a premarket notification submission under this part: (1) Where the device is on the mar- ket, i.e., introduced or delivered for in- troduction into interstate commerce for commercial distribution; (2) Where the person submitting the premarket notification submission has disclosed, through advertising or any other manner, his intent to market the device to scientists, market analysts, exporters, or other individuals who are not employees of, or paid consultants to, the establishment and who are not in an advertising or law firm pursuant Food and Drug Administration, HHS § 807.95 to commercial arrangements with ap- propriate safeguards for secrecy; or (3) Where the device is not on the market and the intent to market the device has not been so disclosed, except where the submission is subject to an exception under paragraph (b) or (c) of this section. (b) The Food and Drug Administra- tion will not disclose publicly the ex- istence of a premarket notification submission for a device that is not on the market and where the intent to market the device has not been dis- closed for 90 days from the date of re- ceipt of the submission, if: (1) The person submitting the pre- market notification submission re- quests in the submission that the Food and Drug Administration hold as con- fidential commercial information the intent to market the device and sub- mits a written certification to the Commissioner: (i) That the person considers his in- tent to market the device to be con- fidential commercial information; (ii) That neither the person nor, to the best of his knowledge, anyone else, has disclosed through advertising or any other manner, his intent to mar- ket the device to scientists, market an- alysts, exporters, or other individuals, except employees of, or paid consult- ants to, the establishment or individ- uals in an advertising or law firm pur- suant to commercial arrangements with appropriate safeguards for se- crecy; (iii) That the person will imme- diately notify the Food and Drug Ad- ministration if he discloses the intent to market the device to anyone, except employees of, or paid consultants to, the establishment or individuals in an advertising or law firm pursuant to commercial arrangements with appro- priate safeguards for secrecy; (iv) That the person has taken pre- cautions to protect the confidentiality of the intent to market the device; and (v) That the person understands that the submission to the government of false information is prohibited by 18 U.S.C. 1001 and 21 U.S.C. 331(q); and (2) The Commissioner agrees that the intent to market the device is con- fidential commercial information. 77 (c) Where the Commissioner deter- mines that the person has complied with the procedures described in para- graph (b) of this section with respect to a device that is not on the market and where the intent to market the device has not been disclosed, and the Com- missioner agrees that the intent to market the device is confidential com- mercial information, the Commissioner will not disclose the existence of the submission for 90 days from the date of its receipt by the agency. In addition, the Commissioner will continue not to disclose the existence of such a submis- sion for the device for an additional time when any of the following occurs: (1) The Commissioner requests in writing additional information regard- ing the device pursuant to § 807.87(h), in which case the Commissioner will not disclose the existence of the submis- sion until 90 days after the Food and Drug Administration’s receipt of a complete premarket notification sub- mission; (2) The Commissioner determines that the device intended to be intro- duced is a class III device and cannot be marketed without premarket ap- proval or reclassification, in which case the Commissioner will not dis- close the existence of the submission unless a petition for reclassification is submitted under section 513(f)(2) of the act and its existence can be disclosed under § 860.5(d) of this chapter; or (d) FDA will make a 510(k) summary of the safety and effectiveness data available to the public within 30 days of the issuance of a determination that the device is substantially equivalent to another device. Accordingly, even when a 510(k) submitter has complied with the conditions set forth in para- graphs (b) and (c) of this section, con- fidentiality for a premarket notifica- tion submission cannot be granted be- yond 30 days after FDA issues a deter- mination of equivalency. (e) Data or information submitted with, or incorporated by reference in, a premarket notification submission (other than safety and effectiveness data that have not been disclosed to § 807.97 the public) shall be available for disclo- sure by the Food and Drug Administra- tion when the intent to market the de- vice is no longer confidential in accord- ance with this section, unless exempt from public disclosure in accordance with part 20 of this chapter. Upon final classification, data and information re- lating to safety and effectiveness of a device classified in class I (general con- trols) or class II (performance stand- ards) shall be available for public dis- closure. Data and information relating to safety and effectiveness of a device classified in class III (premarket ap- proval) that have not been released to the public shall be retained as con- fidential unless such data and informa- tion become available for release to the public under § 860.5(d) or other provi- sions of this chapter. [42 FR 42526, Aug. 23, 1977, as amended at 53 FR 11252, Apr. 6, 1988; 57 FR 18067, Apr. 28, 1992; 59 FR 64296, Dec. 14, 1994] § 807.97 Misbranding by reference to premarket notification. Submission of a premarket notifica- tion in accordance with this subpart, and a subsequent determination by the Commissioner that the device intended for introduction into commercial dis- tribution is substantially equivalent to a device in commercial distribution be- fore May 28, 1976, or is substantially equivalent to a device introduced into commercial distribution after May 28, 1976, that has subsequently been reclas- sified into class I or II, does not in any way denote official approval of the de- vice. Any representation that creates an impression of official approval of a device because of complying with the premarket notification regulations is misleading and constitutes mis- branding. § 807.100 FDA action on a premarket notification. (a) After review of a premarket noti- fication, FDA will: (1) Issue an order declaring the device to be substantially equivalent to a le- gally marketed predicate device; (2) Issue an order declaring the device to be not substantially equivalent to any legally marketed predicate device; (3) Request additional information; or 78 21 CFR Ch. I (4–1–12 Edition) (4) Withhold the decision until a cer- tification or disclosure statement is submitted to FDA under part 54 of this chapter. (5) Advise the applicant that the pre- market notification is not required. Until the applicant receives an order declaring a device substantially equiv- alent, the applicant may not proceed to market the device. (b) FDA will determine that a device is substantially equivalent to a predi- cate device using the following cri- teria: (1) The device has the same intended use as the predicate device; and (2) The device: (i) Has the same technological char- acteristics as the predicate device; or (ii)(A) Has different technological characteristics, such as a significant change in the materials, design, energy source, or other features of the device from those of the predicate device; (B) The data submitted establishes that the device is substantially equiva- lent to the predicate device and con- tains information, including clinical data if deemed necessary by the Com- missioner, that demonstrates that the device is as safe and as effective as a legally marketed device; and (C) Does not raise different questions of safety and effectiveness than the predicate device. (3) The predicate device has not been removed from the market at the initia- tive of the Commissioner of Food and Drugs or has not been determined to be misbranded or adulterated by a judicial order. [57 FR 58403, Dec. 10, 1992, as amended at 63 FR 5253, Feb. 2, 1998] PART 808—EXEMPTIONS FROM FEDERAL PREEMPTION OF STATE AND LOCAL MEDICAL DEVICE REQUIREMENTS Subpart A—General Provisions Sec. 808.1 Scope. 808.3 Definitions. 808.5 Advisory opinions. Subpart B—Exemption Procedures 808.20 Application.