FDA issues draft guidance on third-party device review program

02/20/2013 | Clinica (subscription required)

The FDA has released draft guidance on changes to its program to accredit third-party entities to review certain medical device applications. The draft guidance, based on the International Medical Device Regulators Forum's proposal to create a unified program for medtech auditors, covers compliance with the FDA Safety and Innovation Act, including a provision regarding third-party firm accreditation. Firms must seek reaccreditation every three years.

View Full Article in:

Clinica (subscription required)

Published in Briefs:

SmartBrief Job Listings for Health Care

Job Title Company Location
Paralegal
Mylan Inc.
Washington, DC
Health Care Exchange Account Manager
Kaiser Permanente
San Diego, CA
Director of Actuarial Services, Government Programs
PacificSource
Springfield, OR
Director, Health Plan Claims Operations
Group Health Cooperative
Seattle, WA
Stop Loss Sales Executive
Blue Cross Blue Shield of MA
Boston, MA