[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR807.22]

[Page 62-63]
 
                        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 Domestic 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, Center for Devices 
and Radiological Health (HFZ-307), Food and Drug Administration, 2098 
Gaither Rd., Rockville, MD 20850, or from Food and Drug Administration 
district offices. Subsequent annual registration shall be accomplished 
on Form FDD-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 FD-2892 (Medical Device Listing). Forms are 
obtainable upon request as described in paragraph (a) of this section. A 
separate form FD-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 FD-2892, tapes for computer input or hard copy computer 
output may by submitted if equivalent in all elements of information as 
specified in form FD-2892. All formats proposed for use in lieu of form 
FD-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

[[Page 63]]

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]