CFR - Code of Federal Regulations Title 21

[Code of Federal Regulations]

[Title 21, Volume 8]

[Revised as of April 1, 2012]

[CITE: 21CFR807.35]

TITLE 21--FOOD AND DRUGS

CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES

SUBCHAPTER H--MEDICAL DEVICES

PART 807 -- ESTABLISHMENT REGISTRATION AND DEVICE LISTING FOR MANUFACTURERS AND INITIAL IMPORTERS OF DEVICES

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 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]