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FDA AI medical device regulation received major updates with comprehensive draft guidance for artificial intelligence-enabled devices. On January 7, 2025 , FDA issued draft guidance  for AI-enabled device software functions (DSF)  that applies a Total Product Life Cycle (TPLC)  approach.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...

FDA's new cybersecurity compliance standards carry criminal penalties and RTA threats that can destroy medical device companies. With the...