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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

FDA AI medical device regulation received major updates with comprehensive draft guidance for artificial intelligence-enabled devices. On January 7, 2025 , FDA issued draft guidance  for AI-enabled device software functions (DSF)  that applies a Total Product Life Cycle (TPLC)  approach.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

In FDA device speak, cleared ≠ approved ≠ granted. Mixing these terms can misbrand your product. FDA cleared means 510(k) approval for...

FDA's Safer Technologies Program (STeP)  is a voluntary  program for devices reasonably expected to significantly improve safety  of...

An FDA medical device recall  is usually a voluntary  action by a firm to remove or correct  a product that violates FDA law , with FDA...

A Software Bill of Materials (SBOM)  is a machine-readable inventory  of every software component in your device—proprietary, OTS, and...

In FDA device world, “ cGMP ” obligations are implemented via the Quality System Regulation (21 CFR 820) . On Feb 2, 2026 , FDA’s Quality...

ISO 13485  is the international QMS standard for medical devices. In the U.S., FDA’s QMSR takes effect Feb 2, 2026 , incorporating ISO...

In 510(k) , substantial equivalence (SE)  means your device has the same intended use  as a predicate  and either the same tech...

An RTA hold  happens when a 510(k)  fails FDA’s acceptance review  and is not accepted  for substantive review; you then have 180 days...

eSTAR  is FDA’s interactive PDF template that structures medical-device submissions in the same layout reviewers use, with built-in...

An FDA Pre-Submission (Q-Sub)  is a voluntary  way to get FDA feedback—by written response and/or a meeting—before or during an IDE,...

An HDE  is a marketing application for a Humanitarian Use Device (HUD) —a device intended to treat/diagnose a condition that affects or...