Chapter category: BioMaterials
Regulation of Medical Devices
Biomaterials in the Design and Reliability of Medical Devices
Edited by: Michael N. HelmusISBN: 0-306-47690-8
» Get more information about this book at landesbioscience.com «
Chapter authors:
Barry Sall
The U.S. Food and Drug Administration (FDA) regulates all medical devices sold in the United States. As depicted in Figure 3.1, there are a variety of possible paths that a medical device manufacturer may follow in order to obtain approval or clearance to market products in the U.S. Many of the simpler, Class I, devices are excepted from the premarket review process. Most of these devices raise few, if any, biocompatability issues. The more complex Class II and Class III devices frequently include materials that closely interact with the body. In these cases, biocompatability data can make up a significant portion of the submission. Understanding FDA’s concerns regarding a particular biomaterial and its application will enhance the quality of the submission, and likely accelerate the review process. Medical Device Amendments of 1976 The 1976 Medical Device Amendments to the 1938 Food, Drug and Cosmetic Act (FDCA) gave FDA the responsibility for regulation of medical devices sold in the U.S. Not all devices are regulated in the same manner. Class I devices such as eyeglasses, tooth brushes, scalpels, prosthetic heart valve sizers and stomach pH electrodes are, for the most part, exempt from premarket review by FDA, although they can be subject to some or all quality system (QS) regulation manufacturing and development controls.
Additional chapters from this book:
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Testing of Biomaterials Modified with Bioactive Molecules: A Case Study
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Product Development in a Small Company Environment
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Nonclinical Medical Device Testing
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The goal of nonclinical evaluation is to obtain data from in vitro or in vivo studies that will support the safety and efficacy of a medical device. Medical devices are defined as “...any instrume...
Regulation of Medical Devices
Barry Sall
The U.S. Food and Drug Administration (FDA) regulates all medical devices sold in the United States. As depicted in Figure 3.1, there are a variety of possible paths that a medical device manufactur...
Standards and Guidelines for Biocompatibility of Medical Devices
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Overview and Introduction:Unique Aspects of Biomaterials in the Safety and Efficacy of Medical Implant Devices
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Biomaterials include a broad range of materials that must meet stringent and diverse requirements to be acceptable for use in the body and to meet the needs of specific devices. Biomaterials can be ...
