Regulatory

FDA, NRC, MQSA, state licensing — what governs what.

13 entries

AAPM TG-142 (Linac QA)
AAPM Task Group 142 — the consensus quality-assurance framework for medical linear accelerators in the United States. Published in 2009…
ACR Accreditation
American College of Radiology accreditation for imaging facilities. Required (or near-required, depending on payer) for CMS reimbursement…
EU Medical Device Regulation (MDR)
The European Union's medical-device regulatory framework — Regulation (EU) 2017/745, replacing the prior Medical Device Directive (MDD,…
FDA 510(k) Premarket Notification
The FDA pathway for medical devices substantially equivalent to predicates already legally marketed. The dominant clearance route for…
FDA De Novo Classification
FDA pathway for novel low/moderate-risk devices without a predicate. Less common in imaging capital equipment; more relevant for…
FDA Device Recalls
FDA classifies device recalls as Class I (death/serious injury risk), Class II (temporary/reversible), Class III (unlikely to harm).…
FDA Premarket Approval (PMA)
The most rigorous FDA pathway — full safety and effectiveness review for Class III (high-risk or novel) medical devices. PMA is uncommon…
IEC 60601 (Medical Electrical Safety)
The international electrical-safety standard for medical electrical equipment, published by the International Electrotechnical Commission.…
MAUDE Adverse Event Reporting
Manufacturer and User Facility Device Experience — the FDA adverse-event reporting database. Manufacturers must submit MDRs for serious…
MQSA (Mammography Quality Standards Act)
Mammography Quality Standards Act — 1992 federal law (with subsequent amendments) requiring every U.S. clinical mammography facility to be…
NRC / Agreement State Licensing
Operational guide to obtaining and maintaining a byproduct-material license under the Nuclear Regulatory Commission or the equivalent…
Nuclear Regulatory Commission (NRC)
U.S. federal regulator of byproduct nuclear material — relevant to medical imaging and radiation oncology for PET tracers, Tc-99m…
State Radiation Registration
State-level registration for radiation-producing machines — X-ray tubes, linacs, fluoroscopy systems, mammography units, dental X-ray,…