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FDA authorizes medical devices via three pathways: 510(k) clearance  for substantial equivalence, De Novo classification  for novel low to moderate risk, and PMA (Pre-market) approval  for most Class III devices. Under MDUFA V , FDA’s goals are 510(k): 95% within 90 FDA days , De Novo: 70% within 150 FDA days , and PMA average total time to decision ≈ 285 days in FY 2025–2027 . Your device's risk classification and predicate availability determine which pathway applies. This

FDA AI medical device regulation received major updates with comprehensive draft guidance for artificial intelligence-enabled devices. On January 7, 2025 , FDA issued draft guidance  for AI-enabled device software functions (DSF)  that applies a Total Product Life Cycle (TPLC)  approach. It recommends  what to include in submissions: model description, data lineage/splits, performance tied to claims, bias analysis/mitigation, human-AI workflow, monitoring, and—if you’ll updat

Medical device adverse event reporting MDR (21 CFR Part 803)  requires manufacturers, importers, and device user facilities  to report certain device-related deaths, serious injuries, and malfunctions to FDA. Manufacturers/importers must file electronically (eMDR) since Aug 14, 2015 ; user facilities are not required to e-submit. Manufacturer timelines: 30-day MDRs  and 5-day  reports for urgent risks or when FDA requests. This comprehensive guide provides medical device comp

ISO 14971:2019  is the international standard that defines the lifecycle risk-management process  for medical devices (including SaMD):...

An FDA Warning Letter  is a public advisory  notice that cites significant violations  and requests a written response—typically within...

FDA medical device classification determines the regulatory controls required for your device based on risk level. FDA classifies devices...