21 CFR 1003.20
Notification by the manufacturer to the Secretary
21 CFR 1003.20 is the regulation titled “Notification by the manufacturer to the Secretary” in 21 CFR Part 1003, Notification of Defects or Failure to Comply. Since 2021, 1 FDA warning letter has cited it.
- Letters citing it
- 1 since 2021
- Jan 1 to Oct 30, 2026
- 0 against 0 on the same dates in 2025
- Most often cited with
- 21 CFR 1002.20, 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
- 12024
- 02025
- 02026
The regulation
Read the text of 21 CFR 1003.20 (eCFR, as of Sep 1, 2026)
The notification to the Secretary required by § 1003.10(a) shall be confirmed in writing and, in addition to other relevant information which the Secretary may require, shall include the following:
(a) Identification of the product or products involved;
(b) The total number of such product units so produced, and the approximate number of such product units which have left the place of manufacture;
(c) The expected usage for the product if known to the manufacturer;
(d) A description of the defect in the product or the manner in which the product fails to comply with an applicable Federal standard;
(e) An evaluation of the hazards reasonably related to defect or the failure to comply with the Federal standard;
(f) A statement of the measures to be taken to repair such defect or to bring the product into compliance with the Federal standard;
(g) The date and circumstances under which the defect was discovered; and
(h) The identification of any trade secret information which the manufacturer desires kept confidential.
Text from eCFR as of Sep 1, 2026.
Cited alongside it
Regulations that appear in the same letters as 21 CFR 1003.20.
- 21 CFR 1002.20Reporting of accidental radiation occurrences1 letter cites both
- 21 CFR 1003.10Discovery of defect or failure of compliance by manufacturer; notice requirements1 letter cites both
- 21 CFR 1003.2Defect in an electronic product1 letter cites both
- 21 CFR 1020.30Diagnostic x-ray systems and their major components1 letter cites both
- 21 CFR 1020.31Radiographic equipment1 letter cites both
- 21 CFR 806.10Reports of corrections and removals1 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 1003.20 that FDA posted most recently.
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