510(k)
53 articles
How Much Does a 510(k) Cost? Complete 2026 Budget Breakdown
Budget a 510(k) submission with 2026 FDA user fees, testing, consulting, hidden costs, small business savings, and practical cost-control strategies.
FDA Breakthrough Device Designation: Program Guide for 2026
Guide to FDA Breakthrough Device Designation in 2026, including eligibility criteria, Q-Submission application steps, program benefits, timelines, statistics, and pathway strategy.
FDA Pre-Submission Guide: Get Feedback Before a Device Submission
Guide to FDA's Q-Submission program for medical devices, including Pre-Subs, Submission Issue Requests, Information Meetings, feedback requests, content, timelines, fees, and meeting strategy.
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: 510(k), Special Controls, and Rules
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, Clinical Evidence, and 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: Requirements, Process, and New Device Categories
Guide to FDA De Novo classification, including when to use the pathway, application requirements, special controls, review timelines, and how De Novo creates future predicates.
FDA Product Codes: Classification, Regulation Numbers, and Exemptions
Use FDA product codes to confirm device classification, regulation numbers, 510(k) exemption status, and the likely premarket pathway.
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.
The Complete Guide to FDA 510(k) Submissions
Practical FDA 510(k) submission guide covering predicate selection, substantial equivalence, eSTAR formatting, user fees, common deficiencies, and first-time filing tips.
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.