21 CFR 1003.2
Defect in an electronic product
21 CFR 1003.2 is the regulation titled “Defect in an electronic product” 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 1003.2 (eCFR, as of Sep 1, 2026)
For the purpose of this part, an electronic product shall be considered to have a defect which relates to the safety of use by reason of the emission of electronic product radiation if:
(a) It is a product which does not utilize the emission of electronic product radiation in order to accomplish its purpose, and from which such emissions are unintended, and as a result of its design, production or assembly;
(1) It emits electronic product radiation which creates a risk of injury, including genetic injury, to any person, or
(2) It fails to conform to its design specifications relating to electronic radiation emissions; or
(b) It is a product which utilizes electronic product radiation to accomplish its primary purpose and from which such emissions are intended, and as a result of its design, production or assembly it;
(1) Fails to conform to its design specifications relating to the emission of electronic product radiation; or
(2) Without regard to the design specifications of the product, emits electronic product radiation unnecessary to the accomplishment of its primary purpose which creates a risk of injury, including genetic injury to any person; or
(3) Fails to accomplish the intended purpose.
Text from eCFR as of Sep 1, 2026.
Cited alongside it
Regulations that appear in the same letters as 21 CFR 1003.2.
- 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 1003.20Notification 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 1003.2 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.