E-Book24 chapters # FDA 510(k) and Device Registration Handbook An FDA medical device handbook for hardware startups: classification, the 510(k) process, substantial equivalence, De Novo, QMSR design controls and listing. Most hardware startups building a connected medical device encounter FDA regulation for the first time exactly when it's most expensive to get wrong: mid-development, with a fundraising clock running and a launch date already promised to investors or early customers. This book is built to prevent that collision. It walks through FDA medical device regulation from first principles to complete practical compliance: whether your product actually meets the statutory device definition and how it gets classified, how to choose confidently 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 survives substantive review, design controls and the Quality Management System Regulation that replaces the old Quality System Regulation in 2026, the real testing programme a device actually needs across biocompatibility, electrical safety, software, and human factors, Section 524B medical device cybersecurity requirements, labeling and the UDI system, establishment registration and current FY2026 fees, and the post-market obligations most teams only discover after their first complaint arrives. Every chapter closes with a knowledge check drawn directly from the companion video course, and eight appendices turn the book's worksheets and checklists into templates you can put to work on your own product immediately. This book contains the use of artificial intelligence. ## What you'll learn * 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 * 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 $24.99 One-time purchase · Read in browser · No subscription * 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 Buy for $24.99 Secure checkout via Paddle Not what you expected? Contact us within 14 days. This book is included free when you enroll in the full course — [$199.00 for the complete video curriculum plus this book](/courses/17-fda-medical-device-registration-510k-hardware-startups). Built from a regulatory graph already at work 1,600 users this week 658 guides 323 product types 9 markets ## Chapters Read Chapter 1 free → 1 The Big Picture: Why FDA Regulation Isn't Optional Paperwork Before any classification lookup or pathway decision, it's worth sitting with why this 2 Is Your Product a Medical Device? Scoping and Classification This chapter is the one every later decision in this book depends on. 3 Choosing Your Regulatory Pathway With scoping and classification settled, this chapter walks through how to actually choose 4 The 510(k) Process, End to End This chapter maps the complete 510(k) journey — submission type, the mandatory eSTAR 5 Substantial Equivalence and Predicate Selection Predicate selection is where more 510(k) submissions fail than any other single step. 6 The De Novo Pathway and PMA Overview For genuinely novel devices with no suitable predicate, this chapter covers the De Novo 7 Design Controls and Quality Management: QMSR Arrives This chapter covers the single most consequential regulatory change in this book: the 8 Testing and Evidence: Biocompatibility, Safety, Performance This chapter scopes the real testing programme a device needs — biocompatibility, 9 Software, SaMD, and Clinical Decision Support For any device with a software component — embedded firmware, a companion app, or software 10 Medical Device Cybersecurity: Section 524B Section 524B of the FD&C Act added a mandatory cybersecurity documentation gate for 11 Labeling, UDI, and the GUDID This chapter covers device labeling requirements, the Unique Device Identification system, 12 Establishment Registration, Listing, and Fees This chapter covers who must register with FDA, the annual registration fee, device 13 Post-Market Obligations: MDR, Recalls, Complaint Handling Clearance is not the finish line. 14 Working With FDA: Pre-Submissions, Breakthrough, and Common Pitfalls This chapter covers the Q-Submission programme, the Breakthrough Devices Program, and the 15 Common Failures, Full Walkthrough, and Your Action Plan This closing chapter names the recurring failure patterns from across the book explicitly, 16 Knowledge Checks Every module in this book closes with a knowledge check in the companion video course. 17 Appendix A — Device Classification & Pathway Decision Worksheet 18 Appendix B — 510(k) Predicate Search & Substantial Equivalence Comparison Worksheet 19 Appendix C — Design Controls & DHF/DMR/DHR Checklist 20 Appendix D — Testing Plan Worksheet: Biocompatibility, EMC, Software, Clinical 21 Appendix E — FDA Cybersecurity (Section 524B) Premarket Documentation Checklist 22 Appendix F — UDI & Labeling Compliance Checklist 23 Appendix G — Establishment Registration, Listing & MDUFA Fee Planning Tracker 24 Appendix H — Post-Market Complaint, MDR, and Recall Decision Guide Buy for $24.99 ## Want the full video course? This book's companion course covers the same material with video lessons and downloadable resources — and includes this book free. [ ![FDA 510(k) Course: Medical Device Registration](/posters/17-fda-medical-device-registration-510k-hardware-startups.svg) ](/courses/17-fda-medical-device-registration-510k-hardware-startups) Intermediate2h 28m [ ### FDA 510(k) Course: Medical Device Registration ](/courses/17-fda-medical-device-registration-510k-hardware-startups) FDA medical device registration for hardware startups: classification, 510(k) vs De Novo, predicates, design controls under QMSR, testing and clearance. Includes the ebook, free $199.00[View course →](/courses/17-fda-medical-device-registration-510k-hardware-startups) 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. [See services](/services)