Medical Device Regulation provides the current FDA-CDRH thinking on the regulation of medical devices. This book offers information on how devices meet criteria for being a medical device, which agencies regulate medical devices, how policies regarding regulation affect the market, rules regarding marketing, and laws and standards that govern testing. This practical, well-structured reference tool helps medical device manufacturers both in and out of the United States with premarket application and meeting complex FDA regulatory requirements. The book delivers a comprehensive overview of the field from an author with expertise in regulatory affairs and commercialization of medical devices.
1. Medical Device Regulation - p. Page i 2. Cover - p. Page i 3. Front Matter - p. Page ii 4. Table of Contents - p. Page iii 5. Copyright - p. Page iii 6. Dedication - p. Page vi 7. Biography - p. Page vii 8. Endorsements - p. Page vii 9. Foreword - p. Page viii 10. Acknowledgments - p. Page x 11. List of Illustrations - p. Page xi 12. List of Tables - p. Page xii 13. Chapter 1 : Overview of medical device regulation - p. Page xii 14. Chapter 2 : How to market a medical device - p. Page 31 15. Chapter 3 : Premarket notification [510(k)] - p. Page 56 16. Chapter 4 : Device modifications requiring new 510(k) submission - p. Page 89 17. Chapter 5 : Premarket approval (PMA) - p. Page 112 18. Chapter 6 : Investigational device exemption - p. Page 144 19. Chapter 7 : In vitro diagnostics - p. Page 174 20. Chapter 8 : Clinical studies for medical device - p. Page 201 21. Chapter 9 : Medical device labeling requirements - p. Page 243 22. Chapter 10 : FDA Medical Devices Advisory Committees - p. Page 270 23. Chapter 11 : Human factors and medical devices - p. Page 300 24. Chapter 12 : Mobile medical applications, software, and wireless coexistence - p. Page 319 25. Chapter 13 : Cybersecurity in medical devices - p. Page 344 26. Chapter 14 : Postmarket surveillance and requirements - p. Page 368 27. Chapter 15 : Compliance and enforcement - p. Page 397 28. Chapter 16 : The quality system regulation - p. Page 433 29. Chapter 17 : Risk management - p. Page 453 30. Chapter 18 : Meeting and collaboration with the FDA - p. Page 478 31. Chapter 19 : Future of the medical device industry - p. Page 494 32. Appendix : FDA guidance documents (medical devices) - p. Page 509 33. Regulatory affairs professionals society (RAPS) - p. Page 509 34. Quality management system manual - p. Page 598 35. Glossary - p. Page 616 36. Index - p. Page 624
Medical Device Regulation provides the current FDA-CDRH thinking on the regulation of medical devices. This book offers information on how devices meet criteria for being a medical device, which agencies regulate medical devices, how policies regarding regulation affect the market, rules regarding marketing, and laws and standards that govern testing. This practical, well-structured reference tool helps medical device manufacturers both in and out of the United States with premarket application and meeting complex FDA regulatory requirements. The book delivers a comprehensive overview of the field from an author with expertise in regulatory affairs and commercialization of medical devices.
1. Medical Device Regulation - p. Page i 2. Cover - p. Page i 3. Front Matter - p. Page ii 4. Table of Contents - p. Page iii 5. Copyright - p. Page iii 6. Dedication - p. Page vi 7. Biography - p. Page vii 8. Endorsements - p. Page vii 9. Foreword - p. Page viii 10. Acknowledgments - p. Page x 11. List of Illustrations - p. Page xi 12. List of Tables - p. Page xii 13. Chapter 1 : Overview of medical device regulation - p. Page xii 14. Chapter 2 : How to market a medical device - p. Page 31 15. Chapter 3 : Premarket notification [510(k)] - p. Page 56 16. Chapter 4 : Device modifications requiring new 510(k) submission - p. Page 89 17. Chapter 5 : Premarket approval (PMA) - p. Page 112 18. Chapter 6 : Investigational device exemption - p. Page 144 19. Chapter 7 : In vitro diagnostics - p. Page 174 20. Chapter 8 : Clinical studies for medical device - p. Page 201 21. Chapter 9 : Medical device labeling requirements - p. Page 243 22. Chapter 10 : FDA Medical Devices Advisory Committees - p. Page 270 23. Chapter 11 : Human factors and medical devices - p. Page 300 24. Chapter 12 : Mobile medical applications, software, and wireless coexistence - p. Page 319 25. Chapter 13 : Cybersecurity in medical devices - p. Page 344 26. Chapter 14 : Postmarket surveillance and requirements - p. Page 368 27. Chapter 15 : Compliance and enforcement - p. Page 397 28. Chapter 16 : The quality system regulation - p. Page 433 29. Chapter 17 : Risk management - p. Page 453 30. Chapter 18 : Meeting and collaboration with the FDA - p. Page 478 31. Chapter 19 : Future of the medical device industry - p. Page 494 32. Appendix : FDA guidance documents (medical devices) - p. Page 509 33. Regulatory affairs professionals society (RAPS) - p. Page 509 34. Quality management system manual - p. Page 598 35. Glossary - p. Page 616 36. Index - p. Page 624
