[Code of Federal Regulations]
[Title 21, Volume 4]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR207.7]

[Page 102-103]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 207--REGISTRATION OF PRODUCERS OF DRUGS AND LISTING OF DRUGS IN COMMERCIAL DISTRIBUTION--Table of Contents
 
                           Subpart A--General
 
Sec. 207.7  Establishment registration and product listing for human blood and blood products and for medical devices.

    (a) Owners and operators of human blood and blood product 
establishments shall register and list their products with the Center 
for Biologics Evaluation and Research (HFM-375), 1401 Rockville Pike, 
suite 200N, Rockville, MD 20852-1448, on Form FDA-2830 (Blood 
Establishment Registration and Product Listing), in accordance with part 
607 of this chapter. Such owners and operators who also manufacture or 
process other drug products at the same establishment shall, in 
addition,

[[Page 103]]

register and list all such other drug products with the Drug Listing 
Branch in accordance with this part.
    (b) [Reserved]
    (c) Owners and operators of establishments engaged in manufacture or 
processing of medical devices shall register and list their products 
with the Center for Devices and Radiological Health, FDA, on Form FDA-
2891 (Initial Registration of Device Establishments), FDA-2891a 
(Registration of Device Establishment), and FDA-2892 (Medical Device 
Listing), in accordance with part 807.
    (d) Owners and operators of establishments engaged in the 
manufacture or processing at the same establishment of both drug 
products and medical devices shall (1) register with the Drug Listing 
Branch (HFD-334), Center for Drug Evaluation and Research, FDA, and list 
their drug products in accordance with this part, and (2) register with 
the Center for Devices and Radiological Health and list their medical 
devices in accordance with part 807.

[45 FR 38043, June 6, 1980, as amended at 50 FR 8995, Mar. 6, 1985; 55 
FR 11576, Mar. 29, 1990; 66 FR 59156, Nov. 27, 2001]