PMA
24 articles
Bayesian Statistics for Medical Device Clinical Trials: FDA Guidance & Approvals
Master FDA CDRH guidance for Bayesian device trials. Explore prior borrowing, adaptive designs, 47 PMA approval statistics, and the 2026 drug draft contrast.
FDA Medical Device User Fees FY 2027: MDUFA Rate Table and Budget Decisions
Complete guide to FDA medical device user fee rates for FY 2027 (MDUFA V), covering 510(k), De Novo, PMA, registration fees, small business waivers, and filing decisions.
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 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.
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.
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.
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.
How to Get FDA to Tell You Which Center Will Regulate Your Product: The Pre-RFD Playbook
A comprehensive regulatory guide to FDA's Pre-Request for Designation (Pre-RFD) process for borderline and combination products under the revised November 2025 guidance.
FDA Medical Device Product Codes: Analysis of 7,075 Classification Codes
A data-driven analysis of the FDA Medical Device Classification Database. We parse 7,075 product codes by class, specialty panel, and submission type.
FDA Heart Valve Recalls: Edwards, Medtronic & Abbott MAUDE Teardown
A manufacturer-spanning teardown of FDA heart valve recalls and MAUDE database adverse events, analyzing Class I events and common failure modes.
Coronary & Peripheral Stent Recalls: Boston Scientific, Abbott & Medtronic Teardown
A manufacturer-spanning deep dive into FDA stent recalls and MAUDE adverse event reports. Analyzes 131 recalls, common failure modes, and recent 2025-2026 high-acuity events.
External Defibrillator & AED Recalls: ZOLL, Stryker, Philips & Cardiac Science Teardown
A manufacturer-spanning teardown of automated external defibrillator (AED) and external defibrillator recalls and MAUDE events. Analyzes 373 recalls, common failure modes, and QMS implications.
Baxter FDA Device Footprint: 510(k), PMA, Recall & Manufacturing Analysis
A comprehensive data-driven regulatory profile of Baxter's FDA clearances, PMA approvals, safety recalls, and manufacturing hubs after the Hillrom acquisition.
Becton Dickinson (BD) FDA Device Footprint: 510(k), PMA, Recall & Manufacturing Analysis
A comprehensive data-driven regulatory profile of Becton Dickinson's FDA clearances, PMA approvals, safety recalls, and manufacturing hubs after the 2026 Waters spin-off.
FDA Dermal Filler Approvals and Adverse Events: A 30-Year MAUDE and PMA Analysis
A comprehensive, data-driven analysis of 1,038 FDA dermal filler PMA approvals and 22,247 adverse events from the MAUDE database, detailing trends, top brands, and safety profiles.
FDA Breast Implant Recalls: Allergan, BIA-ALCL, and the 580,000-Report MAUDE Record
Breast implant analysis: 16 Class I FDA recalls (Allergan BIOCELL), 1,380 BIA-ALCL cases, and 580,000 MAUDE reports. Capsular contracture and implant failure lead complications.
FDA Pacemaker and ICD Recalls: 451 Enforcement Actions and the Lead-Failure Record
Pacemaker and ICD analysis: 451 FDA enforcement actions (188 Class I) and 558,000 MAUDE reports. Boston Scientific and Medtronic lead; software and lead-impedance faults dominate Class I.
PMA Supplement Types Explained: 180-Day, Panel-Track, Real-Time, 30-Day, and Special
How to choose the right PMA supplement type under 21 CFR 814.39 — 180-day, panel-track, real-time, 30-day notice, and special — with data on what changes actually drive supplements.
Haemonetics Acquires Vivasure Medical: Vascular Closure Deal Guide
Review Haemonetics' Vivasure acquisition, PerQseal Elite bioabsorbable closure technology, PMA pathway, CE Mark status, ELITE data, and large-bore closure competition.
Humanitarian Device Exemption (HDE): Complete Guide to FDA Rare Disease Device Pathway
Use FDA's HDE pathway for rare disease devices, including HUD designation, probable benefit evidence, HDE applications, profit rules, IRB oversight, QMSR, and post-approval duties.