21 CFR 1002.13
Annual reports
21 CFR 1002.13 is the regulation titled “Annual reports” in 21 CFR Part 1002, Records and Reports. 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 1002.10, 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 1002.13 (eCFR, as of Sep 1, 2026)
(a) Every manufacturer of products requiring an annual report as specified in table 1 of § 1002.1 shall submit an annual report summarizing the contents of the records required to be maintained by § 1002.30(a) and providing the volume of products produced, sold, or installed.
(b) Reports are due annually by September 1. Such reports shall cover the 12-month period ending on June 30 preceding the due date of the report.
[60 FR 48386, Sept. 19, 1995, as amended at 88 FR 3653, Jan. 20, 2023]
Text from eCFR as of Sep 1, 2026.
Cited alongside it
Regulations that appear in the same letters as 21 CFR 1002.13.
- 21 CFR 1002.10Product reports1 letter cites both
- 21 CFR 1010.2Certification1 letter cites both
- 21 CFR 1040.10Laser products1 letter cites both
- 21 CFR 803.17What are the requirements for developing, maintaining, and implementing written MDR procedures that apply to me?1 letter cites both
- 21 CFR 807.81When a premarket notification submission is required1 letter cites both
- 21 CFR 820.184Device history record1 letter cites both
- 21 CFR 820.198Complaint files1 letter cites both
- 21 CFR 820.200Servicing1 letter cites both
Latest letters citing it
The letter citing 21 CFR 1002.13 that FDA posted most recently.
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Counts include every citation in a letter, as the Letters filter does. How this database is built.