Medical Device Regulation

Medical Device Regulation

1st Edition - January 1, 2023

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  • Author: Elijah Wreh
  • Paperback ISBN: 9780323953542

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Medical Device Regulations is a handbook on FDA-CDRH current thinking on regulation of medical devices. This book provides information on how devices are determined to meet criteria for being a medical device, what agencies regulate medical devices, how policies regarding regulation affect the market, rules regarding marketing, and laws and standards that govern testing. This book helps medical device manufacturers both in and out of the United States with premarket application and meeting FDA complex regulatory requirements.Continuous development of medical devices and the associated regulatory affairs is a complex and ever-changing field; this practical, well-structured reference tool will be useful to many professionals in this area. Includes practice exam questions for regulatory affairs certification. This book offers a large and comprehensive overview of the field, and the author has expertise in regulatory affairs and commercialization of medical devices.

Key Features

  • Unique focus on the regulatory affairs industry, specifically targeted at regulatory affairs professionals and those seeking certification
  • Puts regulations in the context of contemporary design
  • Includes case studies and applications of regulations


Regulatory affairs professionals, medical device manufacturers, biomedical engineers working in the field of medical devices. Graduate Master of Science Students in either Regulatory Affairs or Regulatory Science and Law students specializing in Healthcare and Medical Device

Table of Contents

  • 1. Overview of Medical Device Regulation
    2. How 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. Humanitarian Device Exemption
    8. In Vitro Diagnostics
    9. Clinical Trials for Medical Devices
    10. Medical Device Labeling
    11. Overview of Medical Device Classification and Reclassification
    12. FDA Advisory Committees
    13. Human Factors and Medical Devices
    14. Mobile Medical Applications
    15. Cybersecurity and Wireless Coexistence
    16. Postmarket Requirements (Devices)
    17. Compliance & Enforcement
    18. Quality System Regulation (QRS) 
    19. Meeting and Collaboration with FDA
    20. Future of Medical Device Regulation
    Medical Device Single Audit Program (MDSAP)

Product details

  • No. of pages: 350
  • Language: English
  • Copyright: © Academic Press 2023
  • Published: January 1, 2023
  • Imprint: Academic Press
  • Paperback ISBN: 9780323953542

About the Author

Elijah Wreh

Elijah Wreh is an accomplished regulatory affairs leader with a proven track record of success in the medical device industry. Comprehensive experience with bringing medical devices to market from viability through design and, verification, validation to global regulatory approvals. Highly proficient at streamlining procedures, implementing best practices, and pulling a talented group of professionals together into a highly performing team. He is an Adjunct Professor at Case Western Reserve University, Part-Time Lecturer at Northeastern University – College of Professional Studies and guest lecturer at Cleveland State University and the University of Akron. Mr. Wreh’s lecture on regulatory aspects of the medical device product commercialization lifecycle from United States; international perspectives and provisions of the US Food and Drug Administration’s (FDA’s) risk-based medical device classification scheme, such as the Premarket Notification [(510(k)], Pre-Market approval (PMA), and Investigational Device Exemption (IDE) submission processes. He is also a Board Member of CommStar Credit Union in Elyria, OH.

Affiliations and Expertise

Adjunct Professor, Case Western Reserve University; Part-Time Lecturer, Northeastern University and guest lecturer, Cleveland State University and the University of Akron

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