21 CFR 803.50
If I am a manufacturer, what reporting requirements apply to me?
21 CFR 803.50 is the regulation titled “If I am a manufacturer, what reporting requirements apply to me?” in 21 CFR Part 803, Medical Device Reporting. Since 2021, 56 FDA warning letters have cited it.
- Letters citing it
- 56 since 2021
- Jan 1 to Oct 30, 2026
- 7 against 13 on the same dates in 2025
- Most often cited with
- 21 CFR 803.3, in 50 letters
- Closed out
- 20% 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 803.50 most often, as written in the letters.
- 5 lettersFailure to submit a report to FDA no later than 30 calendar days after the day that your firm received or otherwise became aware of information, from any source, that reasonably suggests that a device that your firm…
- 4 lettersFailure to submit a report to FDA no later than 30 calendar days after the day that your firm received or otherwise became aware of information, from any source, that reasonably suggests that a device that your firm…
- 3 lettersFailure to submit a report to FDA no later than 30 calendar days after the day that your firm receives or otherwise become aware of information, from any source, that reasonably suggests that a device that your firm…
The regulation
Read the text of 21 CFR 803.50 (eCFR, as of Sep 1, 2026)
(a) If you are a manufacturer, you must report to us the information required by § 803.52 in accordance with the requirements of § 803.12(a), no later than 30 calendar days after the day that you receive or otherwise become aware of information, from any source, that reasonably suggests that a device that you market:
(1) May have caused or contributed to a death or serious injury or
(2) Has malfunctioned and this device or a similar device that you market would be likely to cause or contribute to a death or serious injury, if the malfunction were to recur.
(b) What information does FDA consider “reasonably known” to me?
(1) You must submit all information required in this subpart E that is reasonably known to you. We consider the following information to be reasonably known to you:
(i) Any information that you can obtain by contacting a user facility, importer, or other initial reporter;
(ii) Any information in your possession; or
(iii) Any information that you can obtain by analysis, testing, or other evaluation of the device.
(2) You are responsible for obtaining and submitting to us information that is incomplete or missing from reports submitted by user facilities, importers, and other initial reporters.
(3) You are also responsible for conducting an investigation of each event and evaluating the cause of the event. If you cannot submit complete information on a report, you must provide a statement explaining why this information was incomplete and the steps you took to obtain the information. If you later obtain any required information that was not available at the time you filed your initial report, you must submit this information in a supplemental report under § 803.56 in accordance with the requirements of § 803.12(a).
Text from eCFR as of Sep 1, 2026.
Cited alongside it
Regulations that appear in the same letters as 21 CFR 803.50.
- 21 CFR 803.3How does FDA define the terms used in this part?50 letters cite both
- 21 CFR 803.17What are the requirements for developing, maintaining, and implementing written MDR procedures that apply to me?39 letters cite both
- 21 CFR 820.100Corrective and preventive action38 letters cite both
- 21 CFR 820.198Complaint files38 letters cite both
- 21 CFR 820.30Design controls35 letters cite both
- 21 CFR 803.18What are the requirements for establishing and maintaining MDR files or records that apply to me?19 letters cite both
- 21 CFR 803.12How do I submit initial and supplemental or followup reports?17 letters cite both
- 21 CFR 807.81When a premarket notification submission is required17 letters cite both
Latest letters citing it
The 3 letters citing 21 CFR 803.50 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 Lion Street Medical, d/b/a Pensar Medical LLCWoundPro Negative Pressure Wound Therapy (NPWT) System, WoundPro+ NPWT System, and MicroDoc (PocketDoc) Portable NPWT SystemIssuedAug 21, 2026PostedSep 22, 2026
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Counts include every citation in a letter, as the Letters filter does. How this database is built.