CFR - Code of Federal Regulations Title 21

[Code of Federal Regulations]

[Title 21, Volume 8]

[Revised as of April 1, 2012]

[CITE: 21CFR807.21]

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. 807.21 Times for establishment registration and device listing.

(a) An owner or operator of an establishment who has not previously entered into an operation defined in 807.20 shall register within 30 days after entering into such an operation and submit device listing information at that time. An owner or operator of an establishment shall update its registration information annually within 30 days after receiving registration forms from FDA. FDA will mail form FDA-2891a to the owners or operators of registered establishments according to a schedule based on the first letter of the name of the owner or operator. The schedule is as follows:

First letter of owner or operator name	Date FDA will mail forms
A, B, C, D, E	March.
F, G, H, I, J, K, L, M	June.
N, O, P, Q, R	August.
S, T, U, V, W, X, Y, Z	November.

(b) Owners or operators of all registered establishments shall update their device listing information every June and December or, at their discretion, at the time the change occurs.

[58 FR 46522, Sept. 1, 1993]