FDA proposes changes to biological review of medical devices

05/13/2013 | Clinica (subscription required)

The FDA has issued draft guidance intended to help companies prepare regulatory submissions for devices that come into contact with the human body directly or indirectly. The guidance, which is up for comment until July 22, outlines changes to how the international standard ISO-10993 should be used to identify possible toxicity issues tied to those devices.

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
Senior Director, Research
America's Health Insurance Plans (AHIP)
Washington, DC