PMA
28 articles
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.
Medical Device Startup Regulatory Strategy: From Concept to FDA Clearance (2026)
Build a startup regulatory strategy covering FDA pathway selection, budgets, Q-Subs, eSTAR templates, QMSR readiness, fundraising alignment, and 2026 accelerator programs.
FDA User Fees 2026: MDUFA Fee Schedule and Small Business Planning
Plan FY 2026 medical device user fees with MDUFA V fee amounts, small business reductions, PMA waivers, registration fees, and cost controls.
PMA Submission Cost: Complete 2026 Budget Breakdown for Class III Devices
Budget FDA PMA submissions for Class III devices with FY 2026 user fees, clinical trial costs, testing, consulting, post-market obligations, and planning benchmarks.
PMA vs 510(k): Differences, Requirements, and How to Choose the Right FDA Pathway
Compare FDA PMA and 510(k) pathways by evidence requirements, review timelines, costs, post-market duties, and decision criteria for US market entry.