21 CFR 803.12
How do I submit initial and supplemental or followup reports?
21 CFR 803.12 is the regulation titled “How do I submit initial and supplemental or followup reports?” in 21 CFR Part 803, Medical Device Reporting. Since 2021, 19 FDA warning letters have cited it.
- Letters citing it
- 19 since 2021
- Jan 1 to Oct 30, 2026
- 3 against 7 on the same dates in 2025
- Most often cited with
- 21 CFR 803.3, in 17 letters
- Closed out
- 16% 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.
What FDA writes when it cites it
The finding headings that cite 21 CFR 803.12 most often, as written in the letters.
- 1 letterFailure to report to the FDA the information required by 21 CFR 803.52 in accordance with the requirements of 21 CFR 803.12(a), no later than 30 calendar days after the day that your firm received or otherwise became…
The regulation
Read the text of 21 CFR 803.12 (eCFR, as of Sep 1, 2026)
(a) Manufacturers and importers must submit initial and supplemental or followup reports to FDA in an electronic format that FDA can process, review, and archive.
(b) User facilities that submit their reports and additional information to FDA electronically must use an electronic format that FDA can process, review, and archive. User facilities that submit their reports to FDA on paper must submit any written report or additional information required under this part to FDA, CDRH, Medical Device Reporting, P.O. Box 3002, Rockville, MD 20847-3002, using Form FDA 3500A. Each report must be identified (e.g., “User Facility Report” or “Annual Report”).
(c) If you are confronted with a public health emergency, this can be brought to FDA's attention by contacting FDA's Office of Crisis Management, Emergency Operations Center by telephone, 24-hours a day, at 301-796-8240 or toll free at 866-300-4374, followed by the submission of an email to: emergency.operations@fda.hhs.gov.
(d) You may submit a voluntary telephone report to the MedWatch office at 800-FDA-1088. You may also obtain information regarding voluntary reporting from the MedWatch office at 800-FDA-1088. You may also find the voluntary Form FDA 3500 and instructions to complete it at: http://www.fda.gov/Safety/MedWatch/HowToReport/DownloadForms/default.htm.
Text from eCFR as of Sep 1, 2026.
Cited alongside it
Regulations that appear in the same letters as 21 CFR 803.12.
- 21 CFR 803.3How does FDA define the terms used in this part?17 letters cite both
- 21 CFR 803.50If I am a manufacturer, what reporting requirements apply to me?17 letters cite both
- 21 CFR 803.17What are the requirements for developing, maintaining, and implementing written MDR procedures that apply to me?16 letters cite both
- 21 CFR 820.30Design controls13 letters cite both
- 21 CFR 820.198Complaint files12 letters cite both
- 21 CFR 820.100Corrective and preventive action11 letters cite both
- 21 CFR 803.18What are the requirements for establishing and maintaining MDR files or records that apply to me?9 letters cite both
- 21 CFR 820.50Purchasing controls8 letters cite both
Latest letters citing it
The 3 letters citing 21 CFR 803.12 that FDA posted most recently.
- DevicesView Olympus Medical Systems CorporationSurgical and endotherapy devices including clips, sphincterotomes, cystoscopes, bronchoscopes, and insufflators.IssuedOct 7, 2026PostedOct 20, 2026
- DevicesView O.N. Diagnostics, LLCVirtuOst and VirtuOst VFA softwareIssuedSep 1, 2026PostedOct 6, 2026
- DevicesView Avertix Medical, Inc.The Guardian SystemIssuedSep 3, 2025PostedMar 17, 2026
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Counts include every citation in a letter, as the Letters filter does. How this database is built.