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 9780323953542
Verwachte levertijd ongeveer 9 werkdagen
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.
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Inhoudsopgave
<p>Section 1: How to Study and Market a Medical Device<br>1. Overview of Medical Device Regulation<br>2. Regulatory Routes to Market a Medical Device<br>3. Premarket Notification 510(k) <br>4. Device Modifications Requiring new 510(k) Submission<br>5. Premarket Approval (PMA)<br>6. Investigational Device Exemption (IDE)<br>7. In Vitro Diagnostics<br>8. Clinical Studies for Medical Device<br>9. Medical Device Labeling<br>10. FDA Advisory Committees<br>11. Human Factors and Medical Devices<br>12. Mobile Medical Applications<br>13. Software, Cybersecurity and Wireless Coexistence </p> <p>Section 2: Postmarket Activities and FDA Collaboration<br>14. Postmarket Activities and Requirements<br>15. Compliance and Enforcement<br>16. Quality System Regulation (QRS)<br>17. Risk Management<br>18. Meeting and Collaboration with FDA<br>19. Future of Medical Device Regulation</p> <p>Appendix<br>A: FDA Guidance Documents (Medical Devices)<br>B: Regulatory Affairs Certification (Devices) Practice Exam Questions<br>C: Quality Management System (QMS) Manual </p>
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