US FDA
21 CFR Part 803 - Medical Device Reporting
Plain-language explanation, inspection context and common violation patterns.
What it says
Manufacturers must report to FDA when they become aware of information reasonably suggesting a device may have caused or contributed to a death or serious injury, or malfunctioned in a way likely to cause death or serious injury if it recurred, with reporting deadlines generally requiring submission within 30 calendar days of becoming aware of a reportable event.
Paraphrased for plain-language clarity. Always verify against the current published regulation text.
What it means in practice
- This provision creates the specific external regulatory reporting obligation that connects to the complaint handling and investigation requirements under 21 CFR 820.198, meaning a single complaint can require both internal investigation and, where criteria are met, external Medical Device Reporting to FDA on its own independent timeline.
- The reasonably suggests standard for triggering a report is deliberately not a high bar requiring confirmed causation, meaning manufacturers must report based on a reasonable possibility the device contributed to an event, not wait for definitive proof before reporting.
- Malfunction reporting, distinct from death or injury reporting, requires assessment of whether a malfunction would likely cause serious harm if it were to recur, requiring genuine risk-based judgment about recurrence potential rather than waiting for an actual injury to occur before reporting a malfunction pattern.
What FDA inspectors look for
- Whether complaints and quality data are correctly assessed against Medical Device Reporting criteria, with reportable events identified and reported within the required 30-day timeline.
- Whether the reasonably suggests standard is applied appropriately, neither over-reporting routine issues nor under-reporting genuine potential harm events while waiting for more certainty than the standard actually requires.
- Whether malfunction trends are assessed for recurrence and potential harm severity, not just treated as isolated technical issues.
Most common violation
A complaint or quality event that met Medical Device Reporting criteria based on the reasonably suggests standard but was not reported within the required timeline, often because the manufacturer waited for a higher degree of causation certainty than the regulation actually requires before reporting.
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