Medical Device & IVD Blog
FDA Medical Device Development Tools (MDDT): Program & Qualified Tools Guide
Complete guide to the FDA Medical Device Development Tools (MDDT) program: 4 tool categories, 2-phase no-fee qualification process, and full matrix of all 21 qualified tools.
Medicare CLFS Under PAMA: What IVD & Diagnostic Developers Must Know in 2026
Comprehensive 2026 guide to Medicare CLFS lab payment under PAMA: applicable lab rules, 3-year CDLT cycle, ADLT status, gapfilling, and CAA 2026 Section 6226 updates.
Teleflex Global Regulatory Dossier: Arrow, UroLift, FDA Data & 2025 Sale
Data-driven regulatory dossier of Teleflex (NYSE: TFX): ~440 FDA 510(k)s, multi-country registration counts, Arrow Class I recalls, and the 2025 $2.03B divestiture.
FDA Medical Device Master Files (MAF): Types, LOA & Sourcing Strategy (2026)
2026 guide to FDA Medical Device Master Files (MAF under 21 CFR 814.20): functional categories, LOA workflow, MAF vs DMF vs DMR, and eSTAR integration.
FDA Regenerative Medicine: 351/361 HCT/P Determination and RMAT Designation
A regulatory and decision framework for cell and gene therapy sponsors: determining 351 BLA vs 361 HCT/P status, qualifying for RMAT designation, and comparing expedited pathways.
MDSAP in 2026: Revised Audit Approach, TGA Migration, and Post-QMSR Value
A strategic evaluation of MDSAP in 2026: analyzing the February 2026 revised audit approach, the TGA mdsap.global migration, and a post-QMSR ROI decision framework.
Defense Production Act & Buy American for Medical Devices (2026)
A decision guide for medical device makers on U.S. domestic incentives: DPA Title III grants, Buy American Act thresholds, TAA exemptions, and tax rules.
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.
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.