United States
146 articles
FDA Medical Device Recalls: Complete Guide to Corrections, Removals, and Recall Classification (21 CFR 7, 806, 810)
Comprehensive guide to FDA medical device recalls — voluntary vs mandatory recalls, Class I/II/III classification, corrections and removals under 21 CFR 806, reporting requirements, recall strategy, health hazard evaluation, and compliance best practices.
FDA Pre-Submission (Q-Submission) Guide: How to Get FDA Feedback Before Your Medical Device Submission
Complete guide to FDA's Q-Submission program — Pre-Submissions, Submission Issue Requests, Information Meetings, how to request FDA feedback, what to include, timeline, fees, and strategies for productive FDA interactions.
FDA Medical Device Reporting (MDR): Complete Guide to Adverse Event Reporting Under 21 CFR Part 803
Comprehensive guide to FDA Medical Device Reporting (MDR) — who must report, what events are reportable, 30-day and 5-day timelines, eMDR electronic submission, complaint handling integration, MAUDE database, and enforcement risks.
Medical Device Change Control: Complete Guide to Managing Design, Process, and Regulatory Changes (FDA & EU MDR)
Comprehensive guide to medical device change control — FDA design change requirements (21 CFR 820.30(i)), EU MDR significant changes (MDCG 2020-3), change classification, Notified Body notification, and change management best practices.
Medical Device Shelf Life & Stability Testing: Complete Guide to Accelerated Aging, Real-Time Aging, and Expiration Dating
Comprehensive guide to medical device shelf life testing — accelerated aging per ASTM F1980, real-time aging studies, sterile barrier system testing, packaging validation, and expiration date justification for FDA and EU MDR submissions.
Medical Device Technical File: Complete Guide to EU MDR Technical Documentation (Annex II & III)
Comprehensive guide to medical device technical documentation — EU MDR Annex II & III requirements, FDA Design History File comparison, STED format, ISO 13485 medical device file, and step-by-step preparation instructions.
Medical Device Clinical Trials: Complete Guide to FDA IDE Requirements, 21 CFR 812, and Investigational Studies
The complete guide to medical device clinical trials — FDA IDE requirements under 21 CFR 812, significant risk vs non-significant risk classification, IDE application process, study design, ISO 14155, costs, timelines, and practical strategies for regulatory professionals.
Companion Diagnostics (CDx): Regulatory Pathways, Development, and Market Access
Complete guide to companion diagnostic device regulation — FDA CDx approval pathways, EU IVDR requirements, co-development with therapeutics, PMA/De Novo strategies, and real-world case studies from oncology to rare diseases.
Medical Device Labeling & UDI System: The Complete Regulatory Guide
Master FDA and EU MDR medical device labeling requirements, UDI system implementation, GUDID database submissions, and global UDI harmonization — practical guide with compliance checklists and common pitfalls.
Medical Device Policy & Legislation: Key Laws Shaping the Industry in 2026
Navigate the evolving medical device legislative landscape — from MDUFA V and the VALID Act to EU MDR implementation challenges, AI regulation, and global policy trends reshaping how devices reach patients.
Point-of-Care Testing (POCT): Regulatory Requirements, CLIA Waivers, and Market Trends
Comprehensive guide to point-of-care testing regulation — CLIA waiver requirements, FDA review pathways for POCT devices, EU IVDR classification, quality management, and the rapidly growing near-patient testing market.
Sustainability & ESG in Medical Devices: Regulatory Drivers, Circular Economy, and Industry Best Practices
How environmental sustainability, ESG reporting, and circular economy principles are transforming medical device design, manufacturing, and regulation — covering EU CSRD, FDA green initiatives, lifecycle assessment, and practical implementation strategies.
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.