Regulatory pathway · all topics

FDA MedWatch and Medical Device Reporting

Medical Device Reporting (MDR) under 21 CFR Part 803 requires manufacturers to report device-related deaths within 30 days, serious injuries within 30 days, malfunctions that could cause death or serious injury within 30 days, and 5-day reports for events requiring remedial action. Reports submitted via the FDA MedWatch electronic system (eMDR). User facilities and importers have separate reporting timelines. Failure to report is a class violation that can trigger warning letters or product seizures.

Source

FDA, '21 CFR Part 803 Medical Device Reporting' and MedWatch system

https://www.fda.gov/medical-devices/medical-device-reporting-mdr-how-report-medical-device-problems

How MedTek OS handles this

Compass drafts the fda medwatch and medical device reporting workflow with confidence-gated content.

The platform refuses to generate content below the threshold for this artifact class. Every claim carries a citation chain back to RIG, audit-logged with HMAC integrity.

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