FDA outlines user fee protocols for medical device applications

04/3/2013 | MassDevice.com (Boston)

The FDA has released a document outlining its user fee guidelines governing premarket approval and 510(k) clearance submissions. The guidance lays out scenarios in which medical device makers may be exempted from user fees or qualified to apply for a user fee refund.

View Full Article in:

MassDevice.com (Boston)

Published in Briefs:

SmartBrief Job Listings for Health Care

Job Title Company Location
Manager/Senior Manager, Health Services Analytics
Avalere Health
Washington, DC
Manager/Senior Manager, Health Economist
Avalere Health
Washington, DC
Director, Health Services Analytics
Avalere Health
Washington, DC
Director/Vice President. Health Actuary
Avalere Health
Washington, DC
Attorney
U.S. DEPARTMENT OF HEALTH & HUMAN SERVICES Food and Drug Administration Office of the Chief Counsel
Silver Spring, MD, MD