FDA Medical Device Reporting: manufacturer deadlines under 21 CFR 803
Once a surgical robot or software device is on the market, manufacturers must report certain adverse events to the FDA. This page summarizes the reporting deadlines set by 21 CFR Part 803.
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The two main deadlines
Manufacturers must submit reports of individual adverse events no later than 30 calendar days after becoming aware of a reportable death, serious injury or malfunction.
A shorter deadline of 5 work days applies to a reportable event that requires remedial action to prevent an unreasonable risk of substantial harm to public health, or to an event for which FDA has made a written request.
Format and awareness
Manufacturers and importers must submit initial and supplemental or followup reports to FDA in an electronic format that FDA can process, review and archive.
A manufacturer becomes aware of an event when any employee becomes aware of a reportable event. For 5-day reports tied to remedial action, awareness also arises when a person with management or supervisory responsibility over regulatory, scientific or technical staff learns, including through trend analysis, that remedial action is needed.
Frequently asked questions
What does remedial action mean in Part 803?
It means any action other than routine maintenance or servicing of a device, where that action is necessary to prevent recurrence of a reportable event.
Do importers have reporting deadlines too?
Yes. Importers must report to the manufacturer and to FDA within 30 calendar days of becoming aware of information suggesting a device may have caused or contributed to a death or serious injury. Reportable malfunctions go to the manufacturer within 30 calendar days.
Is there FDA guidance beyond the regulation itself?
Yes. The base includes the FDA's final guidance on Medical Device Reporting for Manufacturers, which explains how to apply Part 803 in practice.
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