21 CFR 803.10
Generally, what are the reporting requirements that apply to me?
21 CFR 803.10 is the regulation titled “Generally, what are the reporting requirements that apply to me?” in 21 CFR Part 803, Medical Device Reporting. Since 2021, 2 FDA warning letters have cited it.
- Letters citing it
- 2 since 2021
- Jan 1 to Oct 30, 2026
- 0 against 2 on the same dates in 2025
- Most often cited with
- 21 CFR 803.17, in 2 letters
- Closed out
- 0% of these letters have a published close-out
Letters citing it, by year issued
All are medical device letters. 2026 runs to Oct 30, 2026. Pick a year to see its letters.
- 02021
- 02022
- 02023
- 02024
- 22025
- 02026
The regulation
Read the text of 21 CFR 803.10 (eCFR, as of Sep 1, 2026)
(a) If you are a device user facility, you must submit reports (described in subpart C of this part), as follows:
(1) Submit reports of individual adverse events no later than 10 work days after the day that you become aware of a reportable event:
(i) Submit reports of device-related deaths to us and to the manufacturer, if known, or
(ii) Submit reports of device-related serious injuries to the manufacturers or, if the manufacturer is unknown, submit reports to us.
(2) Submit annual reports (described in § 803.33) to us.
(b) If you are an importer, you must submit reports (described in subpart D of this part), as follows:
(1) Submit reports of individual adverse events no later than 30 calendar days after the day that you become aware of a reportable event:
(i) Submit reports of device-related deaths or serious injuries to us and to the manufacturer or
(ii) Submit reports of device-related malfunctions to the manufacturer.
(2) [Reserved]
(c) If you are a manufacturer, you must submit reports (described in subpart E of this part) to us, as follows:
(1) Submit reports of individual adverse events no later than 30 calendar days after the day that you become aware of a reportable death, serious injury, or malfunction.
(2) Submit reports of individual adverse events no later than 5 work days after the day that you become aware of:
(i) A reportable event that requires remedial action to prevent an unreasonable risk of substantial harm to the public health or
(ii) A reportable event for which we made a written request.
(3) Submit supplemental reports if you obtain information that you did not submit in an initial report.
Text from eCFR as of Sep 1, 2026.
Cited alongside it
Regulations that appear in the same letters as 21 CFR 803.10.
- 21 CFR 803.17What are the requirements for developing, maintaining, and implementing written MDR procedures that apply to me?2 letters cite both
- 21 CFR 803.18What are the requirements for establishing and maintaining MDR files or records that apply to me?2 letters cite both
- 21 CFR 803.50If I am a manufacturer, what reporting requirements apply to me?2 letters cite both
- 21 CFR 820.120Device labeling2 letters cite both
- 21 CFR 820.198Complaint files2 letters cite both
- 21 CFR 820.30Design controls2 letters cite both
- 21 CFR 820.80Receiving, in-process, and finished device acceptance2 letters cite both
- 21 CFR 801.20Label to bear a unique device identifier1 letter cites both
Latest letters citing it
The 2 letters citing 21 CFR 803.10 that FDA posted most recently.
- DevicesView Leltek Inc.Ultrasound Imaging System LU700 Series and Ultrasound Imaging System LK128 SeriesIssuedJul 17, 2025PostedJul 22, 2025
- DevicesView Robbins Instruments, LLCDermo-Jet Needleless InjectorIssuedJan 21, 2025PostedFeb 18, 2025
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.