CFR Subpart B

CFR Subpart B
in effect

21 C.F.R. § 807.20 Who must register and submit a device list?

(a) An owner or operator of an establishment not exempt under section 510(g) of the Federal Food, Drug, and Cosmetic Act or subpart D of this part who is engaged in the manufacture, preparation, propagation, compounding, assembly, or processing of a device intended for human use shall register and submit listing information for those devices in commercial distribution, except that registration and listing information may be submitted by the parent, subsidiary, or affiliate company for all the domestic or foreign establishments under the control 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 products 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 establishment located in any State as defined in section 201(a)(1) of the Federal Food, Drug, and Cosmetic Act shall register its name, places of business, and all establishments and list the devices whether or not the output of the establishments or any particular device so listed enters interstate commerce. The registration and listing requirements shall pertain to any person who is engaged in the manufacture, preparation, propagation, compounding, assembly, or processing of a device intended for human use, including any person who: (1) Initiates or develops specifications for a device that is to be manufactured by a second party; (2) Sterilizes or otherwise makes a device for or on behalf of a specifications developer or any other person; (3) Repackages or relabels a device; (4) Reprocesses a single use device that has previously been used on a patient; (5) Acts as an initial importer as defined in § 807.3(g), except that initial importers may fulfill their listing obligation for any device for which they did not initiate or develop the specifications for the device or repackage or relabel the device by submitting the name and address of the manufacturer. Initial importers shall also be prepared to submit, when requested by FDA, the proprietary name, if any, and the common or usual name of each device for which they are the initial importer; (6) Manufactures components or accessories that are ready to be used for any intended health-related purpose and are packaged or labeled for commercial distribution for such health-related purpose, e.g. blood filters, hemodialysis tubing, or devices which of necessity must be further processed by a licensed practitioner or other qualified person to meet the needs of a particular patient, e.g., a manufacturer of ophthalmic lens blanks. (b) Registration or listing does not constitute an admission or agreement or determination that a product is a device within the meaning of section 201(h) of the Federal Food, Drug, and Cosmetic Act. (c) Registration and listing requirements shall not pertain to any person who acts as a wholesale distributor, as defined in § 807.3(t), and who does not manufacture, repackage, process, or relabel a device. (d) Owners and operators of establishments or persons engaged in the recovery, 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 Biologics Evaluation and Research on Form FDA 3356 following the procedures set out in subpart B of part 1271 of this chapter, instead of the procedures for registration and listing contained in this part, except that the additional listing information requirements of § 807.26 remain applicable. (e) Owners and operators of establishments that manufacture devices licensed under section 351 of the Public Health Service Act as well as licensed biological products used in the manufacture of a licensed device must register and list following the procedures set out in part 607 of this chapter, instead of the procedures for registration and listing contained in this part.

21 C.F.R. § 807.21 How to register establishments and list devices.

(a) Owners or operators of establishments that are subject to the registration and listing requirements of this part must provide the following information to us using our electronic device registration and listing system, except as provided in paragraphs (b), (c), and (d) of this section: (1) Initial establishment registration information as required by §§ 807.22(a) and 807.25; (2) Updates to registration information as required by §§ 807.22(b) and 807.25; (3) Initial device listing information as required by §§ 807.22(a), 807.25, and 807.28; (4) Updates to device listing information as required by §§ 807.22(b), 807.25, and 807.28, including updates to reflect the discontinuance or resumption of the commercial distribution of a previously-listed device as specified at paragraphs (d) and (e) of § 807.28. (b) If the information under § 807.21(a) cannot be submitted electronically, a waiver may be requested. Waivers will be granted only if use of electronic means is not reasonable for the person requesting the waiver. To request a waiver, applicants must send a letter to the Imports and Registration and Listing Team, Division of Regulatory Programs 2, Office of Regulatory Programs, Office of Product Evaluation and Quality, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm.1432, Silver Spring, MD 20993-0002, that includes the following information: (1) The name and address of the device establishment(s) to be registered, a contact person for the owner or operator of the establishment, and the telephone number at which that person can be reached. If the establishment has already registered in the past, the letter should also include the owner or operator number, registration number, and any listing numbers previously assigned by FDA for devices manufactured at that establishment. (2) Information about whether the company is an initial importer as defined in § 807.3(g) and, if so, whether it also conducts any other activities or operations relating to devices. (3) A statement that use of the Internet is not reasonable for the person requesting the waiver, and an explanation of why such use is not reasonable. The statement must be signed by the owner or operator of the establishment, or by a person employed by the owner or operator who is authorized to make the declaration on behalf of the owner or operator. (c) Those owners or operators who have obtained a waiver from filing registration and listing information electronically should refer to § 807.34 for information on how to submit such information by postal mail. (d) When additional device listing information (e.g., copies of labeling or advertisements) is requested by FDA as described at § 807.26(e), such information may be submitted by postal mail or electronically by email, but will not be submitted using the FDA electronic device registration and listing system.

21 C.F.R. § 807.22 Times for establishment registration and device listing.

(a) Initial registration and listing. An owner or operator of an establishment who has not previously entered into an operation described in § 807.20(a) shall register within 30 days after entering into such an operation and submit device listing information at that time. (b) Registration and listing updates. Owners or operators shall review and update all of their establishment registration and device listing information that is on file at FDA, documenting any changes that were not previously reported as follows: (1) Annual registration for each fiscal year is required for all establishments. Annual registration shall take place during the period beginning on October 1 and ending on December 31 of each fiscal year; (2) Updates to the registration information as described in § 807.25(b) shall be made within 30 days of any change to such information; (3) Every fiscal year, during the period beginning on October 1 and ending on December 31, owners or operators shall review and update all of their device listing information that is on file at FDA, reporting any changes or deletions to listings and any new listings that were not previously reported. The accuracy of all information on file must be confirmed each year regardless of whether any changes were made to the owner or operator's list of devices; and (4) Changes to listing information may also be made at other times, such as when a device is introduced into commercial distribution, when a change is made to a previously-listed device, or when a previously-listed device is removed from commercial distribution. (c) Failure to submit required information. Failure to submit any of the required information on time, as specified in paragraphs (a) and (b) of this section, will put the establishment in a “failed to register” or “failed to list” status as applicable. The establishment will not be considered active and the establishment registration and device listing information may not appear on the FDA Web site until such time as the owner or operator submits and FDA processes the required information.

21 C.F.R. § 807.25 Information required for device establishment registration and device listing.

(a) All owners or operators that are subject to the registration and listing requirements of this part shall provide such information to us by using the FDA electronic device registration and listing system, unless granted a waiver from electronic submission in accordance with § 807.21(b). Electronic submissions of registration and listing information must comply with part 11 of this chapter, except for the requirements in § 11.10(b), (c), and (e), and the corresponding requirements in § 11.30 of this chapter. Those owners or operators granted a waiver from electronic submission should refer to paragraphs (c) and (g) of this section and § 807.34 for instructions on how to submit device registration and listing information. (b) Registration information required to be submitted includes: The name and mailing address of the device establishment; the Web site address of the device establishment, if any; the name, address, phone number, fax number, and email address of the owner or operator; the name, address, phone number, fax number, and email address of the establishment's official correspondent; and all trade names used by the establishment. (c) Owners or operators who have been granted a waiver from electronic filing must submit the establishment registration information described in paragraph (b) of this section, except for the Web site and email address information, in paper form using the procedures set forth in § 807.34. (d) Each owner or operator is required to maintain a listing of all officers, directors, and partners for each establishment registered by the owner or operator and to furnish this information to FDA upon request. (e) For each establishment, an official correspondent must be designated by the owner or operator to serve as a point of contact with FDA on matters relating to the registration of device establishments and the listing of device products. Each owner or operator shall also provide FDA with the name of a contact person at the owner or operator's offices who will be responsible for identifying the official correspondent for each establishment. The owner or operator contact person will be the official correspondent in the event no one else has been properly designated. The official correspondent is responsible for: (1) Providing FDA with all required registration and listing information electronically unless a waiver from electronic submission has been granted in accordance with § 807.21(b); (2) Receiving all correspondence from FDA concerning registration and listing; (3) Supplying, when requested by FDA, the names of all officers, directors, and partners; and (4) Receiving communications from FDA by email, or by postal mail if the owner or operator has been granted a waiver from the requirement to file registration and listing information electronically. (f) The designation of an official correspondent does not in any manner affect the liability of the owner or operator of the establishment or any other individual under section 301(p) or any other provision of the Federal Food, Drug, and Cosmetic Act. (g) Device listing information must be submitted to FDA electronically unless a waiver from electronic submission has been granted in accordance with § 807.21(b). Owners or operators who have been granted a waiver must submit the required device listing information, including information required by this paragraph, § 807.28, and any listing information requested by FDA under § 807.26(e), in paper form using the procedures set forth in § 807.34. The information required for each device listed includes: (1) The current registration number and name of each establishment under the ownership and control of the owner or operator where the device is manufactured, repackaged, relabeled, or otherwise processed, or where specifications are developed. (2) The product code for each device that is exempt from premarket notification and approval or which was in commercial distribution prior to May 28, 1976. (3) The proprietary or brand name(s) under which each device is marketed. (4) The FDA-assigned premarket submission number of the approved application, cleared premarket notification, granted de novo classification petition, or approved humanitarian device exemption for each device listed that is subject to sections 505, 510(k), 513(f)(2), 515, or 520(m) of the Federal Food, Drug, and Cosmetic Act, which includes devices that are not exempt from premarket notification and approval. (5) Each activity or process that is conducted on or done to the device at each establishment, such as manufacturing, repacking, relabeling, developing specifications, remanufacturing, single-use device reprocessing, contract manufacturing, contract sterilizing, or manufacturing for export only.

21 C.F.R. § 807.26 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: (1) For each device subject to section 514 or 515 of the act that is not a restricted 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 restricted 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 section, each owner or operator shall maintain in the historical file any labeling or advertisements in which a material change has been made anytime after initial listing. (c) Each owner or operator may discard 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 advertising may be used for the purpose of maintaining the historical file as long as the information included in the systems fulfills the requirements of this section, but only if the labeling and advertisements are retrievable in a timely 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 control 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 establishment 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 establishment maintaining the historical file. (e) Each owner or operator shall be prepared to submit to the Food and Drug Administration, only upon specific request, the following information: (1) For a device subject to section 514 or 515 of the act that is not a restricted device, a copy of all labeling for the device. (2) For a device that is a restricted device, a copy of all labeling for the device, a representative sampling of advertisements for the device, and for good cause, a copy of all advertisements for a particular device. A request for all advertisements will, where feasible, be accompanied by an explanation of the basis for such request. (3) For a device that is neither a restricted device, nor subject to section 514 of 515 of the act, the label and package insert for the device and a representative sampling of any other labeling for the device. (4) For a particular device, a statement of the basis upon which the registrant has determined that the device is not subject to section 514 or 515 of the act. (5) For a particular device, a statement of the basis upon which the registrant has determined the device is not a restricted device. (6) For a particular device, a statement of the basis for determining that the product is a device rather than a drug. (7) For a device that the owner or operator has manufactured for distribution under a label other than its own, the names of all distributors for whom it has been manufactured. (f) Labeling, advertisements, and other information to be submitted upon request in accordance with paragraph (e) of this section may be submitted by postal mail or electronically by email, but will not be submitted using the FDA electronic device registration and listing system. Electronic submissions of such information must comply with part 11 of this chapter, except for the requirements in § 11.10 (a), (c) through (h), and (k), and the corresponding requirements in § 11.30 of this chapter. The information provided in electronic format must be in a form that we can process, review, and archive.

21 C.F.R. § 807.28 Updating device listing information.

(a) Updating of device listing information is required if an additional establishment begins to engage in any of the activities described in § 807.3(d) with respect to a listed device, such as manufacturing, developing specifications, repackaging, relabeling, or otherwise processing the device. Updating of the listing is also required if an establishment begins performing another activity on or to the device, or ceases to perform an activity on or to the device that had previously been identified on the device listing. (b) An owner or operator shall create a new device listing using the FDA electronic device registration and listing system: (1) If introducing into commercial distribution an exempt device identified with a product code that is not currently listed by the owner or operator; or (2) If introducing into commercial distribution a non-exempt device with an FDA premarket submission number that is not currently listed by the owner or operator. (c) All device listings for foreign establishments must be submitted before the device may be imported or offered for import into the United States. (d) An owner or operator who discontinues commercial distribution of a device shall discontinue the device listing using the FDA electronic device registration and listing system. A device listing is considered discontinued if: (1) All devices under an exempt product code have been discontinued or (2) All devices associated with an FDA premarket submission number have been discontinued. (e) If commercial distribution of a discontinued device is resumed, the owner or operator must reactivate the previously-discontinued listing using the electronic device registration and listing system. Any changes to the listing information for the product that is the subject of the listing such as a new establishment, new activity, or new proprietary name must be made using the electronic device registration and listing system at the time the listing is reactivated. (f) FDA will assign one listing number for all devices exempt from premarket notification requirements under a single product code. For products not exempt from premarket notification requirements, a single listing number will be assigned by FDA for each FDA premarket submission number.

21 C.F.R. § 807.34 Summary of requirements for owners or operators granted a waiver from submitting required information electronically.

(a) For initial registration and listing, owners or operators who have been granted a waiver from electronic filing using the procedures set forth in § 807.21(b) must send a letter containing all of the registration and listing information described in §§ 807.22, 807.25 (and § 807.26 when such information is requested by FDA), at the times described in § 807.22, to: The Imports and Registration and Listing Team, Division of Regulatory Programs 2, Office of Regulatory Programs, Office of Product Evaluation and Quality, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 1432, Silver Spring, MD 20993-0002. (b) As specified in § 807.22(b)(1) and (b)(3), all owners or operators shall update their establishment registration and device listings annually during the period beginning on October 1 and ending on December 31 of each fiscal year. (c) Failure to submit any of the required information on time, as specified in § 807.22(a) and (b), will put the establishment in a “failed to register” or “failed to list” status as applicable. The establishment will not be considered active and the establishment registration and device listing information may not appear on the FDA Web site until the required information is submitted to and processed by FDA.

21 C.F.R. § 807.35 Notification of registrant.

(a) The Food and Drug Administration will assign each device establishment a registration number after verifying the initial establishment registration information that has been submitted. The owner or operator of the establishment will also be assigned an identifying number. Both numbers will be sent to the official correspondent by email, or by postal mail if the owner or operator has been granted a waiver from the requirement to file registration and listing information electronically. (b) Owners or operators of device establishments who also manufacture or process biological products (including devices licensed under section 351 of the Public Health Service Act) or drug products at the same establishment must also register and list those products under part 607 or part 207 of this chapter, as appropriate. Registration and listing for human blood and blood products, devices licensed under section 351 of the Public Health Service Act, and licensed biological products used in the manufacture of a device licensed under section 351 of the Public Health Service Act, are subject to part 607 of this chapter; registration and listing for all other drug products (including other biological products that are also regulated as drug products) are subject to part 207 of this chapter. (c) Although establishment registration and device listing are required to engage in the device activities described in § 807.20, validation of registration and the assignment of a device listing number in itself does not establish that the holder of the registration 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.

21 C.F.R. § 807.37 Public availability of establishment registration and device listing information.

(a) Establishment registration and device listing information is available for public inspection in accordance with section 510(f) of the Federal Food, Drug, and Cosmetic Act and will be posted on the FDA website, with the exception of the information identified in paragraph (b) of this section. Requests for information by persons who do not have access to the internet should be directed to the Imports and Registration and Listing Team, Division of Regulatory Programs 2, Office of Regulatory Programs, Office of Product Evaluation and Quality, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm.1432, Silver Spring, MD 20993-0002. In addition, there will be available for inspection at each of the Food and Drug Administration district offices the same information for firms within the geographical area of such district offices. Upon request, verification of a registration number or location of a registered establishment will be provided. (b) The following listing information will not be available for public inspection or posted on the FDA Web site: (1) For contract manufacturers, contract sterilizers, and private label manufacturers, the proprietary or brand name(s) under which a device is marketed and the FDA-assigned premarket submission number, if this information would reveal a confidential business relationship; (2) FDA-assigned listing numbers.

21 C.F.R. § 807.39 Misbranding by reference to establishment registration or to registration number.

Registration of a device establishment or assignment of a registration number does not in any way denote approval of the establishment or its products. Any representation that creates an impression of official approval because of registration or possession of a registration number is misleading and constitutes misbranding.

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