Which regulatory concept is defined by 21 CFR Part 803?

• A. Adverse event reporting and post-market surveillance
• B. Device labeling requirements
• C. Clinical trial enrollment
• D. Import/export controls

Answer: (A)

Adverse event reporting and post-market surveillance for medical devices. 21 CFR Part 803 defines Medical Device Reporting (MDR) requirements, outlining when adverse events or device malfunctions must be reported to the FDA and what responsibilities manufacturers, importers, and user facilities have to maintain records and submit reports. This regulation is about monitoring safety after a device is on the market and acting on signals of potential risk to patients. It’s focused on reporting and surveillance, not on labeling or on enrolling patients in clinical trials. For contrast, labeling is addressed under another regulation, and clinical trial enrollment falls under separate device investigation rules.