CFR > Title 21 - Food and Drugs > CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES > SUBCHAPTER H—MEDICAL DEVICES (parts 800 to 898) > PART 807—ESTABLISHMENT REGISTRATION AND DEVICE LISTING FOR MANUFACTURERS AND INITIAL IMPORTERS OF DEVICES > SUBPART B—Procedures for Device Establishments (§807.20 to §807.39) > 807.22—How and where to register establishments and list devices.

807.22—How and where to register establishments and list devices.

(a) The first registration of a device establishment shall be on Form FDA-2891 (Initial Registration of Device Establishment). Forms are available upon request from the Food and Drug Administration, Center for Devices and Radiological Health, Office of Compliance, 10903 New Hampshire Ave., Bldg. 66, rm. 3521, Silver Spring, MD 20993-0002, or from Food and Drug Administration district offices. Subsequent annual registration shall be accomplished on Form FDA-2891a (Annual Registration of Device Establishment), which will be furnished by FDA to establishments whose registration for that year was validated under § 807.35(a). The 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 separate form FDA-2892 shall be submitted for each device or device class listed with the Food and Drug Administration. 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 information as specified in form FDA-2892. All formats proposed for use in lieu of form FDA-2892 require initial review and approval by the Food and Drug Administration.”
(c) The listing obligations of the initial importer are satisfied as follows:
(1) The initial importer is not required to submit a form FDA-2892 for those devices for which such initial importer did not initiate or develop the specifications for the device or repackage 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 requested 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.

Code of Federal Regulations

[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]