Title:
The medical device industry : science, technology, and regulation in a competitive environment
ISBN:
9780824782689
Added Author:
Available:*
Library | Item Barcode | Call Number | Material Type | Item Category 1 | Status |
---|---|---|---|---|---|
Searching... | 30000001250343 | HD9994.U52M42 1990 | Open Access Book | Book | Searching... |
On Order
Summary
Summary
Practical information about the complexities of biomedical technology and regulation, and their implications for manufacturers and marketers of health care devices. Written primarily for those in the industry concerned about staying competitive in light of complex and fluctuating regulatory approach
Table of Contents
.. . Introduction |
Focus on Patient Care Historic Overview/Legal Framework of the Regulatory |
Environment A History of Government Regulation of Adulteration and Misbranding of Medical Devices |
Medical Device Regulation: The Big Picture FDA's Regulatory Program for Medical Devices |
Overview of Current FDA Requirements for Product Approvals Responding as Organizations to the Regulatory |
Environment CDRH's Medical Device Laboratories |
The FDA's Role in Assisting Small Manufacturers Precautionary |