FDA releases guidance on clinical trials backing PMA applications

08/17/2011 | MassDevice.com (Boston)

The FDA has issued another guidance outlining the basic features of clinical trials designed to support medical devices seeking premarket approval, which will be up for comment over the next three months. The guidance, which may also be applicable to 510(k) submissions, "will help manufacturers and researchers better understand the FDA's basic expectations for clinical trials," said Dr. Jeffrey Shuren, director of the FDA's device center.

View Full Article in:

MassDevice.com (Boston)

Published in Brief:

SmartBrief Job Listings for Health Care

Job Title Company Location
Chief Executive Officer
Center for Improving Value in Healthcare
Denver, CO
Quality Program Manager II, State Programs
Tufts Health Plan
Watertown, MA
Associate Director, Promotion Integrity
Bristol-Myers Squibb
Plainsboro, NJ
Vice President, Medicare Advantage
BCBS-Louisiana
Baton Rouge, LA
Director, Global Integrity and Compliance, Pharmaceuticals
Alcon
Fort Worth, TX