Overview
Medical Devices Law and Regulation Answer Book walks you through the current regulatory requirements governing medical devices and describes every aspect from pre-market requirements for specific types of devices to post-market regulation and ongoing government enforcement and investigation. The organization of this text broadly follows the typical life cycle of a device and covers a broad range of topics, including many that are not commonly included in surveys of this field. Coverage includes the legal framework of FDA regulation of medical devices; clinical trials; COVID-19 policies; manufacturing compliance; the Quality System Regulation; and interacting with FDA and government enforcement and device commercialization and related issues.
With contributions from more than two dozen of the world’s leading experts in medical device regulation, this comprehensive work distills the complexities of FDA medical device regulation into a single practical guide that will be of value to virtually everyone doing business in the medical device sector — including lawyers, consultants, companies operating in the medical device sector, and individual or entity contemplating entry into this field.