[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: 21CFR807.25]

[Page 69-70]
 
                        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. 807.25  Information required or requested for establishment
registration and device listing.

    (a) Form FDA-2891 and Form FDA-2891(a) are the approved forms for 
initially providing the information required by the act and for 
providing annual registration, respectively. The required information 
includes the name and street address of the device establishment, 
including post office code, all trade names used by the establishment, 
and the business trading name of the owner or operator of such 
establishment.
    (b) The owner or operator shall identify the device activities of 
the establishment such as manufacturing, repackaging, or distributing 
devices.
    (c) Each owner or operator is required to maintain a listing of all 
officers, directors, and partners for each establishment he registers 
and to furnish this information to the Food and Drug Administration upon 
request.
    (d) Each owner or operator shall provide the name of an official 
correspondent 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 listing of device 
products. All future correspondence 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 operator of the 
establishment will be the official correspondent.
    (e) 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 act.
    (f) Form FD-2892 is the approved form for providing the device 
listing

[[Page 70]]

information required by the act. This required information includes the 
following:
    (1) The identification by classification name and number, 
proprietary name, and common or usual name of each device being 
manufactured, prepared, propagated, compounded, or processed for 
commercial distribution that has not been included in any list 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 Administration 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 
domestic or foreign device establishment under joint ownership and 
control of the owner or operator at which the device 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 requested on form FDA-2892, i.e.,
    (i) If the submission refers to a previously listed device, as in 
the case of an update, the document number from the initial listing 
document for the device,
    (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 information (e.g., specification 
sheets or catalogs) adequate to describe the intended use of a device 
when the owner or operator is unable to find an appropriate 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]