21 CFR 807.22
Times for establishment registration and device listing
21 CFR 807.22 is the regulation titled “Times for establishment registration and device listing” in 21 CFR Part 807, Establishment Registration and Device Listing for Manufacturers and Initial Importers of Devices. Since 2021, 1 FDA warning letter has cited it.
- Letters citing it
- 1 since 2021
- Jan 1 to Oct 30, 2026
- 0 against 1 on the same dates in 2025
- Most often cited with
- 21 CFR 801.20, in 1 letter
- Closed out
- 0% of these letters have a published close-out
Letters citing it, by year issued
It is a medical device letter. 2026 runs to Oct 30, 2026. Pick a year to see its letters.
- 02021
- 02022
- 02023
- 02024
- 12025
- 02026
The regulation
Read the text of 21 CFR 807.22 (eCFR, as of Sep 1, 2026)
(a) Initial registration and listing. An owner or operator of an establishment who has not previously entered into an operation described in § 807.20(a) shall register within 30 days after entering into such an operation and submit device listing information at that time.
(b) Registration and listing updates. Owners or operators shall review and update all of their establishment registration and device listing information that is on file at FDA, documenting any changes that were not previously reported as follows:
(1) Annual registration for each fiscal year is required for all establishments. Annual registration shall take place during the period beginning on October 1 and ending on December 31 of each fiscal year;
(2) Updates to the registration information as described in § 807.25(b) shall be made within 30 days of any change to such information;
(3) Every fiscal year, during the period beginning on October 1 and ending on December 31, owners or operators shall review and update all of their device listing information that is on file at FDA, reporting any changes or deletions to listings and any new listings that were not previously reported. The accuracy of all information on file must be confirmed each year regardless of whether any changes were made to the owner or operator's list of devices; and
(4) Changes to listing information may also be made at other times, such as when a device is introduced into commercial distribution, when a change is made to a previously-listed device, or when a previously-listed device is removed from commercial distribution.
(c) Failure to submit required information. Failure to submit any of the required information on time, as specified in paragraphs (a) and (b) of this section, will put the establishment in a “failed to register” or “failed to list” status as applicable. The establishment will not be considered active and the establishment registration and device listing information may not appear on the FDA Web site until such time as the owner or operator submits and FDA processes the required information.
[77 FR 45942, Aug. 2, 2012]
Text from eCFR as of Sep 1, 2026.
Cited alongside it
Regulations that appear in the same letters as 21 CFR 807.22.
- 21 CFR 801.20Label to bear a unique device identifier1 letter cites both
- 21 CFR 801.3Definitions1 letter cites both
- 21 CFR 801.40Form of a unique device identifier1 letter cites both
- 21 CFR 806.10Reports of corrections and removals1 letter cites both
- 21 CFR 807.65Exemptions for device establishments1 letter cites both
- 21 CFR 807.81When a premarket notification submission is required1 letter cites both
- 21 CFR 820.100Corrective and preventive action1 letter cites both
- 21 CFR 820.198Complaint files1 letter cites both
Latest letters citing it
The letter citing 21 CFR 807.22 that FDA posted most recently.
See the letter citing 21 CFR 807.22 →Put this kind of reading to
work on your own records.
Botable builds and runs a custom AI layer around the software you already use, so your team can do the job you hired them for.
Counts include every citation in a letter, as the Letters filter does. How this database is built.