[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: 21CFR807.35]

[Page 72]
 
                        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. 807.35  Notification of registrant.

    (a) The Commissioner will provide to the official correspondent, at 
the address listed on the form, a validated copy of Form FDA-2891 or 
Form FDA-2891(a) (whichever is applicable) as evidence of registration. 
A permanent registration number will be assigned to each device 
establishment registered in accordance with these regulations.
    (b) Owners and operators of device establishments who also 
manufacture or process blood or drug products at the same establishment 
shall also register with the Center for Biologics Evaluation and 
Research and Center for Drug Evaluation and Research, as appropriate. 
Blood products shall be listed with the Center for Biologics Evaluation 
and Research, Food and Drug Administration, pursuant to part 607 of this 
chapter; drug products shall be listed with the Center for Drug 
Evaluation and Research, Food and Drug Administration, pursuant to part 
207 of this chapter.
    (c) Although establishment registration and device listing are 
required to engage in the device activities described in Sec. 807.20, 
validation of registration and the assignment of a device listing number 
in itself does not establish that the holder of the registration is 
legally qualified to deal in such devices and does not represent a 
determination by the Food and Drug Administration as to the status of 
any device.

[69 FR 11312, Mar. 10, 2004]