21 CFR 803.50: If I am a manufacturer, what reporting requirements apply to me?
Manufacturers must report to FDA within 30 calendar days of becoming aware of information suggesting their device may have caused or contributed to a death or serious injury, or malfunctioned likely to do so if recurring, investigating each event and obtaining missing information.
Part 803, Medical Device Reporting · Subpart E, Manufacturer Reporting Requirements
How FDA words it
The opening lines investigators use most when they cite 803.50, from the 483s we hold.
An MDR report was not submitted within 30 days of receiving or otherwise becoming aware of information that reasonably suggests that a marketed device has malfunctioned and would be likely to cause or contribute to a death or…Most used
Cited over time
483s citing 803.50, by yearMost citations in 2023. Bars are relative to the busiest year. *2026 to date.
Years shown: 2017 to 2026. The busiest year was 2023.
Recent 483s citing 803.50
- Philips Oral Healthcare, LLC · Bothell, WashingtonAn MDR report was not submitted within 30 days of receiving or otherwise becoming… May 8, 2026
- MicroTransponder, Inc · Lakeway, TexasAn MDR report was not submitted within 30 days of receiving or otherwise becoming… Mar 19, 2026
- BioTissue Holdings Inc · Doral, FloridaAn MDR report was not submitted within * of receiving or otherwise becoming aware… Feb 18, 2026
- ZIIP INC · Pleasant Hill, CaliforniaAn MDR report was not submitted within 30 days of receiving or otherwise becoming… Jan 12, 2026
- Baxalta US Inc · Thou sand Oak s, CaliforniaAn MDR report was not submitted within 30 days of receiving or otherwise becoming… Sep 18, 2025
The regulation text
§ 803.50 If I am a manufacturer, what reporting requirements apply to me?.
(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).
Questions
What does 21 CFR 803.50 require?
Manufacturers must report to FDA within 30 calendar days of becoming aware of information suggesting their device may have caused or contributed to a death or serious injury, or malfunctioned likely to do so if recurring, investigating each event and obtaining missing information.
How do FDA investigators word a 803.50 observation?
The most common opening is: “An MDR report was not submitted within 30 days of receiving or otherwise becoming aware of information that reasonably suggests that a marketed device has malfunctioned and would be likely to cause or contribute to a death or…”
Which sections are cited alongside 803.50?
In the same 483s, investigators most often also cite 820.100 (Corrective and preventive action), 820.198 (Complaint files), 820.30 (Design controls), 820.50 (Purchasing controls).