Home > Newsletters > International Medical Device Regulatory Monitor > U.S. FDA Guidance Outlines Device Risk, Benefit Analysis
International Medical Device Regulatory Monitor
September 2011 | Vol. 19 No. 9
U.S. FDA Guidance Outlines Device Risk, Benefit Analysis
To illustrate how reviewers analyze device applications and make their recommendations for approval, a new U.S. Food and Drug Administration (FDA) draft guidance distills benefit-risk analysis of devices into a series of topics and questions and offers a worksheet on key considerations.
ePublishing :: CMS, Hosting & Web Development | © Copyright by FDAnewsAll rights reserved. Do not duplicate or redistribute in any form.