21 CFR 803.56
If I am a manufacturer, in what circumstances must I submit a supplemental or followup report and what are the requirements for such reports?
21 CFR 803.56 is the regulation titled “If I am a manufacturer, in what circumstances must I submit a supplemental or followup report and what are the requirements for such reports?” in 21 CFR Part 803, Medical Device Reporting. Since 2021, 4 FDA warning letters have cited it.
- Letters citing it
- 4 since 2021
- Jan 1 to Oct 30, 2026
- 1 against 2 on the same dates in 2025
- Most often cited with
- 21 CFR 803.17, in 4 letters
- Closed out
- 25% 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.
The regulation
Read the text of 21 CFR 803.56 (eCFR, as of Sep 1, 2026)
If you are a manufacturer, when you obtain information required under this part that you did not provide because it was not known or was not available when you submitted the initial report, you must submit the supplemental information to us within 30 calendar days of the day that you receive this information. You must submit the supplemental or followup report in accordance with the requirements of § 803.12(a). On a supplemental or followup report, you must:
(a) Indicate that the report being submitted is a supplemental or followup report;
(b) Submit the appropriate identification numbers of the report that you are updating with the supplemental information (e.g., your original manufacturer report number and the user facility or importer report number of any report on which your report was based), if applicable; and
(c) Include only the new, changed, or corrected information.
Text from eCFR as of Sep 1, 2026.
Cited alongside it
Regulations that appear in the same letters as 21 CFR 803.56.
- 21 CFR 803.17What are the requirements for developing, maintaining, and implementing written MDR procedures that apply to me?4 letters cite both
- 21 CFR 803.3How does FDA define the terms used in this part?4 letters cite both
- 21 CFR 803.50If I am a manufacturer, what reporting requirements apply to me?4 letters cite both
- 21 CFR 801.20Label to bear a unique device identifier3 letters cite both
- 21 CFR 801.3Definitions3 letters cite both
- 21 CFR 801.40Form of a unique device identifier3 letters cite both
- 21 CFR 820.198Complaint files3 letters cite both
- 21 CFR 830.3Definitions3 letters cite both
Latest letters citing it
The 3 letters citing 21 CFR 803.56 that FDA posted most recently.
- DevicesView Physitemp Instruments, LLCClinical Electronic Thermometers (TH-5; TH-5/AOP; TH-8; TH-8/AOP), Clinical Temperature Monitoring Probes (OT-1; ESO-1; RET-1; SST-1;…IssuedNov 12, 2025PostedMar 31, 2026
- DevicesView Diasol, Inc.Disinfectants for hemodialysis systems, including Diasol and Citrisol concentratesIssuedJan 29, 2026PostedMar 3, 2026
- DevicesView Insung Medical Co. Ltd.ANKOR Endobronchial TubeIssuedSep 23, 2025PostedSep 30, 2025
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Counts include every citation in a letter, as the Letters filter does. How this database is built.