United States
146 articles
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.
The Complete Guide to FDA 510(k) Submissions
Everything you need to know about the FDA 510(k) process — from predicate device selection and substantial equivalence to eSTAR formatting, user fees, common deficiencies, and first-time submission tips.
MDSAP Audit: The Complete Guide to the Medical Device Single Audit Program
Everything about MDSAP — the single audit program covering FDA, Health Canada, TGA, ANVISA, and MHLW. Audit process, grading, preparation, costs, and how to pass.
FDA's QSR to QMSR Transition: What Medical Device Companies Need to Know
The FDA is aligning its Quality System Regulation with ISO 13485. Here's what the QMSR final rule means for your quality management system and what you need to do to prepare.
FDA Medical Device Classification: Product Codes, Device Classes, and Regulatory Pathways
How FDA classifies medical devices into Class I, II, and III — product codes, regulation numbers, how to determine your device's classification, and what it means for your regulatory pathway.
Medical Device Reimbursement: The Complete Guide to Coding, Coverage, and Payment
How medical devices get reimbursed — coding systems, CMS coverage pathways, private payer strategy, health technology assessment, and building a reimbursement strategy from day one.