Which document or regulation governs post-market surveillance for medical devices in the US?

• A. FDA post-market surveillance requirements (adverse event reporting under 21 CFR Part 803).
• B. ISO 9001
• C. HIPAA
• D. IEC 62304

Answer: (A)

Post-market surveillance is about monitoring a medical device’s safety once it’s on the market to catch issues that didn’t appear in premarket testing. In the United States, the primary way this safety monitoring is regulated is through the FDA’s Medical Device Reporting (MDR) system, which is codified in 21 CFR Part 803. This regulation requires manufacturers and importers (and certain user facilities) to report to the FDA when they become aware of information suggesting that a device may have caused or contributed to a death or serious injury, or that a device has malfunctioned in a way that would likely cause death or serious injury if it were to recur. The MDR framework creates a structured flow of adverse event data to the FDA, enabling ongoing safety oversight, trend analysis, and regulatory actions if needed.

Other options don’t fit this specific US regulatory mechanism. ISO 9001 is a general quality management standard, not a post-market safety reporting rule for devices in the US. HIPAA governs privacy and security of health information, not device safety reporting. IEC 62304 addresses the software development life cycle for medical device software, not post-market surveillance.