Elijah Wreh,
Elijah (Adjunct Professor, Case Western Reserve University; Part-Time Lecturer, Northeastern University and guest lecturer, Cleveland State University and the University of Akron) Wreh
Medical Device Regulation
FDA-CDRH Manufacturing, Policies and Regulation Handbook
Paperback Engels 2023 9780323953542Levertijd ongeveer 9 werkdagen
Gratis verzonden
Samenvatting
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.
Specificaties
ISBN13:9780323953542
Taal:Engels
Bindwijze:Paperback
Aantal pagina's:678
Uitgever:Elsevier Science
Hoofdrubriek:Wetenschap en techniek, Juridisch
Lezersrecensies
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Inhoudsopgave
Section 1: How to Study and Market a Medical Device
1. Overview of Medical Device Regulation
2. Regulatory Routes to Market a Medical Device
3. Premarket Notification 510(k)
4. Device Modifications Requiring new 510(k) Submission
5. Premarket Approval (PMA)
6. Investigational Device Exemption (IDE)
7. In Vitro Diagnostics
8. Clinical Studies for Medical Device
9. Medical Device Labeling
10. FDA Advisory Committees
11. Human Factors and Medical Devices
12. Mobile Medical Applications
13. Software, Cybersecurity and Wireless Coexistence
Section 2: Postmarket Activities and FDA Collaboration
14. Postmarket Activities and Requirements
15. Compliance and Enforcement
16. Quality System Regulation (QRS)
17. Risk Management
18. Meeting and Collaboration with FDA
19. Future of Medical Device Regulation
Appendix
A: FDA Guidance Documents (Medical Devices)
B: Regulatory Affairs Certification (Devices) Practice Exam Questions
C: Quality Management System (QMS) Manual
1. Overview of Medical Device Regulation
2. Regulatory Routes to Market a Medical Device
3. Premarket Notification 510(k)
4. Device Modifications Requiring new 510(k) Submission
5. Premarket Approval (PMA)
6. Investigational Device Exemption (IDE)
7. In Vitro Diagnostics
8. Clinical Studies for Medical Device
9. Medical Device Labeling
10. FDA Advisory Committees
11. Human Factors and Medical Devices
12. Mobile Medical Applications
13. Software, Cybersecurity and Wireless Coexistence
Section 2: Postmarket Activities and FDA Collaboration
14. Postmarket Activities and Requirements
15. Compliance and Enforcement
16. Quality System Regulation (QRS)
17. Risk Management
18. Meeting and Collaboration with FDA
19. Future of Medical Device Regulation
Appendix
A: FDA Guidance Documents (Medical Devices)
B: Regulatory Affairs Certification (Devices) Practice Exam Questions
C: Quality Management System (QMS) Manual
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