FDA proposal on device recalls draws industry concerns

05/31/2013 | MassDevice.com (Boston) · Bloomberg BNA (free content)

The FDA's draft guidance clarifying its requirements on medical device recalls has elicited concerns from the industry. "[W]e believe significant aspects of the Draft Guidance are at odds with existing FDA regulation and policy, and that it is necessary to resolve these discrepancies prior to issuing guidance or regulation in this area," AdvaMed said. Boston Scientific echoed AdvaMed's concerns, saying the guidance "has not achieved its purpose in clarifying the difference between product enhancements and recalls."

View Full Article in:

MassDevice.com (Boston) · Bloomberg BNA (free content)

Published in Briefs:

SmartBrief Job Listings for Health Care

Job Title Company Location
MGR POST MARKET STUDIES - 14000001LK
Abbott
Santa Ana, CA
Regulatory Analyst
Delta Dental
Alpharetta, GA
Eastern Zone Sales Director
Regenesis Biomedical
Multiple Locations, SL_Multiple Locations
Senior Financial Analyst - Growing Manager Care Health Org
Fallon Community Health Plan
Worcester, MA
Associate Director, Regulatory Affairs - Promotional Review
Novo Nordisk
Princeton, NJ