[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: 21CFR807.21]

[Page 68]
 
                        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. 807.21  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 Sec. 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]