MedDeviceGuide — IVD & Medical Device Knowledge Base
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.
DMEPOS Prior Authorization for Devices: Master, Required & the 2026 Exemption
A comprehensive guide to traditional Medicare DMEPOS prior authorization. Understand the Master and Required lists, the 2026 updates, and the 90% supplier exemption.
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.
Medicare Advantage Prior Authorization for Medical Devices: Navigating the 2026 Rules
A comprehensive guide to Medicare Advantage prior authorization for medical devices. Learn about CMS-0057-F timelines, CY2026 rules, denial rates, and appeal strategies.
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.
Bundled Payments for Medical Devices: BPCI-Advanced, CJR & Implant Pricing
A strategic playbook for medical device companies navigating CMS bundled payment models (BPCI-Advanced, CJR). Dissects implant pricing and NTAP/OPPS exclusions.
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.
Outcomes-Based & Value-Based Contracts for Medical Devices: Commercial Playbook
A comprehensive guide to structuring outcomes-based and value-based contracts for medical devices. Analyzes OIG safe harbors, Stark Law, metrics, and case studies.
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.
Hospital Value Analysis Committees and GPOs: How US Medical Devices Get Bought
Playbook on US hospital Value Analysis Committees (VAC) and Group Purchasing Organizations (GPOs). Explains evaluation rubrics and contracting pathways.
HEOR and the Global Value Dossier: Building Device Evidence That Wins Reimbursement
A guide to HEOR and Global Value Dossier strategy for medical devices. Dissects device-specific economic modeling and payer evidence requirements.
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.
Aesthetic Device Market Structure: FDA 510(k) and PMA Approvals Analysis
A data-driven map of the US aesthetic medical device market, analyzing 510(k) energy devices, the laser oligopoly, PMA implants (dermal fillers and breast implants), and recalls.
EU PFAS Restriction for Medical Devices: REACH Timelines and Derogations
How the EU REACH PFAS restriction affects medical device components, key transition timelines (5- and 12-year derogations), concentration limits, and substitution roadmaps.