Medical Devices Law and Regulation Answer Book 2015
- ISBN-10
- 1402422601
- ISBN-13
- 9781402422607
- Category
- Medical instruments and apparatus
- Language
- English
- Published
- 2014-10-07
- Authors
- Karen M. Becker, Suzan Onel
Description
The regulation of medical devices has grown increasingly complex since the Medical Device Amendments to the Federal Food, Drug and Cosmetic Act (FDCA) were introduced in 1976. This title walks you through the current regulatory requirements and describes every aspect from pre-market requirements for specific types of devices to post-market regulation and ongoing government enforcement and investigation. Topics include: Overview of Medical Device Regulation in the U.S; Clinical Studies of Investigational Devices; Device Premarket Submissions; Devices with Unique Issues Combination Devices, Radiological Devices, Restricted Devices, Customer Devices, Device Software; Licensing, Product Development and Commercialization * FDA Criminal Enforcement * Overlapping Jurisdiction with other Agencies and Law Enforcement Entities * Commonly Used Acronyms"
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