[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2008]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR807.22]

[Page 68-69]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 807_ESTABLISHMENT REGISTRATION AND DEVICE LISTING FOR 
MANUFACTURERS AND INITIAL IMPORTERS OF DEVICES--Table of Contents
 
             Subpart B_Procedures for Device Establishments
 
Sec. 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 Office of Compliance,

[[Page 69]]

Center for Devices and Radiological Health (HFZ-308), Food and Drug 
Administration, 9200 Corporate Blvd., Rockville, MD 20850-4015, 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 
Sec. 807.35(a). The forms will be mailed to the owner or operators of 
all establishments via the official correspondent in accordance with the 
schedule as described in Sec. 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 Sec. 
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]