PMA
5 articles
Humanitarian Device Exemption (HDE): Complete Guide to FDA Rare Disease Device Pathway
Comprehensive guide to the FDA Humanitarian Device Exemption (HDE) pathway for rare disease medical devices — HUD designation process, HDE application requirements, probable benefit standard, profit restrictions, IRB oversight, post-approval obligations, QMSR implications, and step-by-step instructions.
Medical Device Startup Regulatory Strategy: From Concept to FDA Clearance (2026)
A practical regulatory strategy guide for medical device startups — covering FDA pathway selection, budget planning, Q-Sub pre-submissions, eSTAR templates, QMSR compliance, fundraising alignment, and the programs that accelerate market entry in 2026.
FDA User Fees 2026: Complete MDUFA Fee Schedule, Small Business Program & Strategic Planning Guide
Everything you need to know about FDA medical device user fees for FY 2026 (October 2025–September 2026) — covering the complete MDUFA V fee schedule, small business determination program, first PMA waiver, new establishment registration fee waiver, year-over-year comparisons, and strategies to minimize your regulatory costs.
PMA Submission Cost: Complete 2026 Budget Breakdown for Class III Devices
A comprehensive cost breakdown for FDA Premarket Approval (PMA) submissions — covering user fees, clinical trials, consulting, testing, and post-market obligations — with FY 2026-specific figures for Class III medical device manufacturers.
PMA vs 510(k): Differences, Requirements, and How to Choose the Right FDA Pathway
A detailed comparison of FDA's PMA and 510(k) pathways — clinical evidence requirements, review timelines, costs, post-market obligations, and a decision framework for choosing the right route to market.