FDA releases proposals to update device approval process

08/3/2010 | Wall Street Journal, The

The FDA on Tuesday released a set of proposals with the aim of clarifying which devices can use the 510(k) approval process and when medical evidence is mandatory for approval. Advanced Medical Technology Association President and CEO Stephen J. Ubl said the recommendations "could result in a significant disruption to a program that has served patients well for more than 30 years." The agency is also proposing a Class IIb category of devices, which would include drug infusion pumps.

View Full Article in:

Wall Street Journal, The

Published in Brief:

SmartBrief Job Listings for Health Care

Job Title Company Location
President/Chief Executive Officer
Winston-Salem, NC
Consumer Directed Health Plan (CDH) Product Offering Manager
Blue Cross Blue Shield MA
Quincy, MA
Director, Payer Marketing
Avalere Health
Washington, DC
Meridian Health Plan
Detroit, MI
Chief Medical Officer, Texas Children's Health Plan
Cejka Executive Search for Texas Childre's Health Plan
Houston, TX