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The FDA’s Center for Devices and Radiological Health (CDRH) regulates medical devices in the United States. Devices reach the market via...

FDA maintains 15+ medical device databases containing approval data , adverse events , manufacturer information , and regulatory guidance . The most critical are the 510(k) database for predicate devices, PMA database for Class III research, Product Classification for device codes, and MAUDE for safety intelligence. Smart companies use these databases for competitive intelligence , faster regulatory submissions , and market analysis . Most regulatory professionals waste hour

Medical device clinical trials are FDA-regulated clinical investigations  conducted under 21 CFR 812  to collect safety and effectiveness...

Medical device post-market surveillance is a comprehensive FDA requirement for manufacturers to systematically monitor device...

FDA is replacing 21 CFR 820 (Quality System Regulation) with the Quality Management System Regulation (QMSR) on February 2, 2026,...

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