CDRH develops draft guidance for two device-exemption types

08/20/2008 | FDAnews

The FDA's Center for Devices and Radiological Health has released a draft guidance aimed at helping researchers, institutional review boards and device-trial sponsors distinguish between humanitarian device exemptions and investigational device exemptions. With an HDE, manufacturers are not required to provide a reasonable proof of effectiveness. An exemption for an IDE indicates that some rules do not have to be followed to perform a clinical study of an unapproved product, according to the guidance.

View Full Article in:

FDAnews

Published in Brief:

SmartBrief Job Listings for Health Care

Job Title Company Location
Sr. Regulatory Specialist, Biotech Center of Expertise
BASF, The Chemical Co.
San Diego, CA
Food Lawyer
Cargill
Wayzata, MN
Director of Clinical Research
Regenesis Biomedical, Inc.
Scottsdale, AZ
Actuary
Meridian Health Plan
Detroit, MI
Assistant Vice President - Dental Director
MetLife
Bridgewater, NJ