PMA
28 articles
Medical Device Expanded Access: Emergency Use, Compassionate Use & Treatment IDE
Operational guide to US investigational device expanded access: emergency use, compassionate use IDE supplements, Treatment IDE (21 CFR 812.36), and IRB rules.
Protocol Deviations in Medical Device Clinical Trials: FDA Guidance and EU Rules
Comprehensive guide to protocol deviations in medical device clinical trials: FDA draft guidance, 21 CFR 812, EU MDR Article 75, ISO 14155:2026, and BIMO metrics.
Sham Controls in Medical Device Trials: Design, Ethics, and FDA/EU Expectations
Comprehensive guide to sham controls in medical device clinical trials: 21 CFR 860.7, EU MDR Article 62, Helsinki ethics, blinding protocols, and alternatives.
External and Historical Control Arms in Medical Device Clinical Trials
Guide to external and historical control arms in medical device trials: FDA acceptance, OPC vs external controls, MAIC, and exchangeability rules.
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.