21 CFR 1003.10
Discovery of defect or failure of compliance by manufacturer; notice requirements
21 CFR 1003.10 is the regulation titled “Discovery of defect or failure of compliance by manufacturer; notice requirements” 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 1003.10 (eCFR, as of Sep 1, 2026)
Any manufacturer who discovers that any electronic product produced, assembled, or imported by him, which product has left its place of manufacture, has a defect or fails to comply with an applicable Federal standard shall:
(a) Immediately notify the Secretary in accordance with § 1003.20, and
(b) Except as authorized by § 1003.30, furnish notification with reasonable promptness to the following persons:
(1) The dealers or distributors to whom such product was delivered by the manufacturer; and
(2) The purchaser of such product and any subsequent transferee of such product (where known to the manufacturer or where the manufacturer upon reasonable inquiry to dealers, distributors, or purchasers can identify the present user).
(c) If a manufacturer is required to notify the Secretary under paragraph (a) of this section and also is required to report to the Food and Drug Administration under part 803 of this chapter, the manufacturer shall report in accordance with part 803. If a manufacturer is required to notify the Secretary under paragraph (a) of this section and is not required to report to the Food and Drug Administration under part 803, the manufacturer shall notify the Secretary in accordance with paragraph (a) of this section.
[38 FR 28628, Oct. 15, 1973 and 49 FR 36351, Sept. 14, 1984]
Text from eCFR as of Sep 1, 2026.
Cited alongside it
Regulations that appear in the same letters as 21 CFR 1003.10.
- 21 CFR 1002.20Reporting of accidental radiation occurrences1 letter cites both
- 21 CFR 1003.2Defect in an electronic product1 letter cites both
- 21 CFR 1003.20Notification by the manufacturer to the Secretary1 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 1003.10 that FDA posted most recently.
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