Medical Device Safety and Regulation
Medical Device Safety and Regulation
This domain tests how devices reach and stay on the market, how risks are controlled, and how problems are reported. Expect classification, premarket pathways, post-market surveillance, recalls, and standards.
Core rules
- U.S. FDA pathways: 510(k) for substantial equivalence to a predicate; De Novo for novel low/moderate-risk devices; PMA for high-risk devices. Clearance is not "approval."
- Risk management follows ISO 14971: identify hazards, estimate and evaluate risk, control, verify, and monitor production and post-production.
- IEC 60601-1 covers basic safety and essential performance; collateral standards add particular requirements.
- Post-market tools include UDI, MDR reporting, recalls, and safety communications. Report deaths and serious injuries within 30 days; certain urgent cases within 5 days.
Worked example
A vendor changes an infusion pump's drug-library software. Does it need a new 510(k)? Ask whether the change affects safety or effectiveness. If it alters dose-error-reduction limits or creates a new alarm algorithm, it likely does; a cosmetic label change does not. Document the decision in a letter-to-file with rationale.
Traps
- Calling 510(k) "FDA approval."
- Missing software as a medical device (SaMD) and cybersecurity changes.
- Reporting only injuries while ignoring required malfunction reports.