FDA guidance aims to clarify device enhancements, recalls

02/26/2013 | MassDevice.com (Boston)

Draft guidance released by the FDA aims to clarify scenarios where changes to medical device design warrant a recall and help medtech firms differentiate those cases from product enhancements that do not constitute a recall. The guidance also outlines the regulatory standards for reporting a recall or product enhancement.

View Full Article in:

MassDevice.com (Boston)

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