Medical Device Regulation

FDA-CDRH Manufacturing, Policies and Regulation Handbook

Elijah Wreh

• Publisher: Academic Press
• Year: 2023
• ISBN:
  9780323953535
• Topic: Tecnologia e ingegneria
• Subtopic: Ingegneria generale

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.

• Offers a 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

Table of contents

• Cover image
• Title page
• Table of Contents
• Copyright
• Dedication
• Biography
• Endorsements
• Foreword
• Acknowledgments
• Section 1. How to study and market a medical device
• Section 2. Postmarket activities and FDA collaboration
• Appendix. FDA guidance documents (medical devices)
• Regulatory affairs professionals society (RAPS)
• Quality management system manual
• Glossary
• Index