Regulatory
567 articles
FDA Medical Device Advisory Committees: Panel Referral & Prep (2026)
Guide to FDA Medical Devices Advisory Committee (MDAC) panel referrals under Section 515(c), voting mechanics, sponsor preparation, and TAP vs FDORA 3302.
How to Choose a Medical Device CRO: Selection & Due Diligence (2026)
Vendor-neutral guide to selecting a medical device CRO: ISO 14155:2026 and ICH E6(R3) compliance, RFP execution, FDA 483 due diligence, and cost models.
FCPA Compliance for Medical Device Manufacturers: 2025 Shifts and Case Record
A guide to US FCPA compliance for medical device manufacturers, covering the 2025 DOJ guidelines, historical cases, distributor red flags, and QMS controls.
FDA Pediatric Medical Device Regulation: Pathways, Section 515A, and Waivers
A guide to US FDA pediatric device regulation: Section 515A submissions, premarket pathways, MDUFA user-fee waivers, extrapolation, and PDC grants.
Medicare OPPS Device Pass-Through: CY2026 Categories and Criteria
A guide to Medicare OPPS transitional pass-through device payments, covering CY2026 categories, 42 CFR 419.66 criteria, and the FDA Breakthrough pathway.
EU MDR Article 97 Derogations: Legacy Device Contingency Playbook
Comprehensive guide to EU MDR Article 97 derogations, including MDCG 2022-18, Addendum 1 restrictions, national competent authority processes, and contingency planning.
Aesthetic Medical Device Adverse Events and Recalls: A MAUDE Data Analysis
A data-driven analysis of FDA MAUDE adverse events and recalls across aesthetic device classes, analyzing breast implants, lasers, dermal fillers, and cryolipolysis systems.
FDA Safer Technologies Program (STeP) for Medical Devices: Complete Regulatory Guide
A comprehensive guide to the FDA Safer Technologies Program (STeP) in 2026, including eligibility criteria, safety-innovation factors, Q-Submission application steps, benefits, and TAP pilot updates.
Medicare Coverage with Evidence Development (CED) for Medical Devices
A comprehensive guide to Medicare Coverage with Evidence Development (CED) in 2026, mapping active device NCDs, study and registry requirements, and the graduation timeline.
FDA Early Feasibility Studies (EFS): The Strategic Playbook for Novel Medical Devices
A comprehensive guide to the FDA Early Feasibility Studies (EFS) Program for medical devices. Dissects EFS IDE protocols, risk mitigation, and OHT routing.
Certificate of Need (CON) for Medical Devices: State-by-State Guide
State-by-state guide to Certificate of Need (CON) rules for capital medical devices. Map reviewable equipment, thresholds, and sales strategy.
FDA AI-Enabled Medical Device Guidance: Transparency, Labeling & GMLP
Guide to FDA AI medical device rules. Map GMLP, June 2024 transparency, and January 2025 draft guidance to submission and labeling artifacts.
FDA Import Alerts & DWPE for Medical Devices: The Border Gate
Guide to FDA Import Alerts and Detention Without Physical Examination (DWPE) for medical devices. Learn the Red List removal and petition workflow.
Panama Medical Device Registration: The DNDM Law 90 Compliance Guide
A comprehensive regulatory guide to medical device registration and licensing in Panama under DNDM, Law 90, Executive Decree 490, and Law 419.
Burundi Essential Medical Devices List Teardown: ABREMA 2025
A data-driven teardown of Burundi's National Essential Medical Devices List (2025). Analyze the risk-class split, clinical-service mix, WHO-style tomes, and ABREMA legal framework.
Malawi PMRA Medical Device Register Teardown: Supplier Landscape
A data-driven teardown of Malawi's PMRA Medical Device Register. Analyze the supplier landscape, geographic concentration, registration timeline, and PMRA legal framework.
Mongolia Diagnostic & IVD Device Register Teardown: 2024 LMMD Reset
A data-driven teardown of Mongolia's diagnostic and IVD register. Analyze the risk-class split, country-of-origin mix, top manufacturers, and 2024 LMMD regulatory reset.
DR Congo ACOREP Register: China's 51% Share and Local Agent Lock-in
A quantitative teardown of the DR Congo medical device register under ACOREP, analyzing import dependency, local agent concentration, and product categories.
Lebanon MoPH Authorized Implantable Medical Devices Teardown
A detailed analysis of Lebanon's Ministry of Public Health implantable medical device register under Decree 455/1, examining risk classes, manufacturers, and supplier dynamics.
Adaptive AI Medical Devices: Why an FDA PCCP Won't Update Your Model in the EU or Japan
A cross-market analysis of AI medical device change control, comparing the US FDA PCCP, Japan's IDATEN framework, and the EU's MDR and AI Act modification rules.