Intermediate2h 28m # FDA 510(k) Course: Medical Device Registration FDA medical device registration for hardware startups: classification, 510(k) vs De Novo, predicates, design controls under QMSR, testing and clearance. Getting FDA classification wrong, picking the wrong predicate, or treating design controls as paperwork to backfill before submission are the ordinary, recurring ways hardware startups lose months and fundraising momentum to an avoidable refuse-to-accept or not-substantially-equivalent decision. None of this is exotic — it's a process problem, and it's fixable with the right framework applied from day one of development. This course teaches FDA medical device regulation from first principles to complete practical compliance: whether your product meets the statutory device definition and how it gets classified, how to choose between the 510(k), De Novo, and PMA pathways, exactly how the 510(k) process runs end to end under the mandatory eSTAR system and the MDUFA review clock, how to build a substantial equivalence argument and select a predicate that actually holds up, design controls and the new Quality Management System Regulation replacing the old Quality System Regulation in 2026, the real testing programme — biocompatibility, electrical safety and EMC, software verification and validation, human factors, and sterilization — software and SaMD documentation, Section 524B medical device cybersecurity requirements including SBOMs and vulnerability management, labeling and the UDI system, establishment registration and the current MDUFA fee schedule, and the post-market obligations around complaints, MDR reporting, and recalls that most courses skip entirely. Every module ends with a knowledge check, and the final module walks a realistic connected medical device through the entire compliance process end to end before turning what you've learned into your own action plan. Common failure patterns — mismatched predicates, retroactive design history files, stale cybersecurity documentation — are covered as they occur throughout the course, not just listed once at the end. Built on Krono's regulatory database and current FY2026 FDA guidance, fee schedules, and compliance dates. This course contains the use of artificial intelligence for asthetic purposes. * Includes the ebook edition, free * 8 downloadable resources included ## What you'll learn * Build a substantial equivalence argument and select a predicate that survives substantive review * Set up design controls and a QMSR-aligned quality system alongside development, not after it * Scope a real testing programme across biocompatibility, electrical safety, software, and human factors * Meet Section 524B cybersecurity requirements, including SBOMs and a vulnerability management plan * Handle labeling, UDI, registration, MDUFA fees, and post-market MDR and recall obligations ## Requirements * ·No prior FDA regulatory experience required — the course starts from first principles * ·Some familiarity with hardware product development or medical device engineering is helpful but not essential * ·Founders, regulatory affairs staff, quality engineers, and hardware engineering leads will all benefit $199.00 One-time purchase · Lifetime access · No subscription Less than one hour with a compliance consultant. [First lesson free to preview: FDA Medical Device Registration & 510(k)](#lesson-acf8d0b5-f128-4503-a374-0629e8bef738) * Determine whether your product meets the statutory device definition and how it gets classified * Choose confidently between the 510(k), De Novo, and PMA pathways for your specific device * Run the 510(k) process end to end under eSTAR and the MDUFA review clock, avoiding refuse-to-accept Includes the ebook edition, free — read it in your [library](/platform/books) after purchase. Enroll — $199.00 Secure checkout via Paddle Not what you expected? Contact us within 14 days. Built from a regulatory graph already at work 1,600 users this week 658 guides 323 product types 9 markets ## Course content 16 modules·148 min total FDA Medical Device Regulation: The Big Picture Preview9 min Is Your Product a Medical Device? Scoping and Classification 10 min Choosing Your Regulatory Pathway 11 min The 510(k) Process End to End 9 min Substantial Equivalence and Predicate Selection 8 min The De Novo Pathway and PMA Overview 8 min Design Controls and Quality Management: QMSR Arrives 10 min Testing and Evidence: Biocompatibility, Safety, Performance 11 min Software, SaMD, and Clinical Decision Support 10 min Medical Device Cybersecurity: Section 524B 9 min Labeling, UDI, and the GUDID 10 min Establishment Registration, Listing, and Fees 10 min Post-Market Obligations: MDR, Recalls, Complaint Handling 9 min Working With FDA: Pre-Submissions, Breakthrough, and Common Pitfalls 11 min Common Failures, Full Walkthrough, and Your Action Plan 12 min What's Next 0 min Enroll — $199.00 Need more than one? The **All-Access Krono Vault** unlocks every course and book for one payment, or put your whole team on it with **Krono Team Vault**. [See pricing](/pricing) Short on time? ### Rather hand it over than learn it? One consultant from Krono's compliance team takes your product from requirements to legal sale, with a fixed quote before any work starts. 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