[Code of Federal Regulations]
[Title 21, Volume 4]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR207.7]

[Page 101]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                                SERVICES
 
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 Division 
of Product Certification, Office of Biological Product Review (HFB-240), 
Center for Biologics Evaluation and Research, 8800 Rockville Pike, 
Bethesda, MD 20892, on Form FDA-2830 (Blood Establishment Registration 
and Product Listing), in acordance with part 607. Such owners and 
operators who also manufature or process other drug products at the same 
establishment shall, in addition, 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]

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