United States
14 articles
510(k) Predicate Devices: How to Find, Evaluate, and Select the Right Predicate
Step-by-step guide to finding and selecting predicate devices for FDA 510(k) submissions — search strategies, substantial equivalence criteria, split predicates, and common selection mistakes.
FDA 510(k) Database: How to Search, Find Predicates, and Use Clearance Data
Step-by-step guide to searching the FDA 510(k) database — finding predicate devices, reading clearance summaries, using openFDA API, and leveraging 510(k) data for regulatory strategy.
FDA Class I Medical Devices: General Controls, Exemptions, and Regulatory Requirements
The complete guide to FDA Class I medical devices — general controls, 510(k) exemptions, GMP requirements, device listing, and what 'low risk' really means for regulatory compliance.
FDA Class II Medical Devices: The Complete Guide to Regulations, 510(k), and Special Controls
Everything you need to know about FDA Class II medical devices — special controls, 510(k) requirements, exemptions, device examples, and how to navigate the regulatory pathway.
FDA Class III Medical Devices: PMA Requirements, Clinical Evidence, and the Path to Approval
The complete guide to FDA Class III medical devices — PMA applications, clinical trial requirements, pre-amendment devices, user fees, and what makes Class III the highest-risk regulatory category.
FDA De Novo Classification: Pathway Requirements, Process, and How to Create a New Device Category
The complete guide to FDA's De Novo classification pathway — when to use it, application requirements, special controls development, review timelines, and how De Novo creates new predicates for future devices.
FDA MAUDE Database: The Complete Guide to Searching and Using Medical Device Adverse Event Reports
How to search, interpret, and use the FDA MAUDE database — report types, data fields, search techniques, limitations, and practical applications for regulatory professionals.
FDA Product Codes: How to Look Up Device Classification, Regulation Numbers, and Exemption Status
The complete guide to FDA product codes — how to search the Product Classification Database, understand device classification, check 510(k) exemption status, and determine your regulatory pathway.
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.