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A Predetermined Change Control Plan (PCCP) is FDA documentation that lets you pre-define specific AI/ML software changes—and the methods...

FDA consensus standards are voluntary international standards that FDA recognizes for medical device submissions. Companies can submit a...

Medical device development runs from concept through design controls, verification and validation, clinical investigations when needed,...

FDA requires packaging that protects devices from alteration or damage  through processing, storage, handling, and distribution ( 21 CFR...

Medical device development costs vary by classification: Class I ($200K-$2M), Class II ($2M-$30M), and Class III ($5M-$119M+). Major expenses include clinical trials (40-60% of budget), regulatory activities (10-15%), manufacturing setup (15-25%), and commercialization (10-20%). Timeline spans 1-7 years depending on complexity and pathway. The #1 question every medtech entrepreneur asks: "How much funding do I actually need?" The answer depends on your device classification,

In the US, reimbursement for medical devices rests on three pillars: coding , coverage , and payment . Coding assigns CPT/HCPCS  and,...

FDA Design Controls under 21 CFR 820.30 are quality system requirements ensuring medical devices are designed to meet user needs and...

UDI  is FDA’s Unique Device Identification  system: most device labels and packages  must carry a UDI  in machine-readable (AIDC)  and...

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

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...