Draft rules on investigational device exemption trials unveiled

11/14/2011 | MassDevice.com (Boston)

The FDA has unveiled two draft guidance documents for products seeking investigational device exemption. The first details new feasibility research approaches to guide a product's final design better and enable studies to start sooner, while the second describes the process for approving clinical trials. The agency also launched an amended standard operating procedure for obtaining new data from devices undergoing premarket evaluation.

View Full Article in:

MassDevice.com (Boston)

Published in Briefs:

SmartBrief Job Listings for Health Care

Job Title Company Location
Manager, Business Conduct
Gilead
Foster City, CA
Product Patent Attorney
Gilead
Foster City, CA
Employment Counsel
Gilead
Foster City, CA
Junior to Mid-Level FDA Associate
Morgan Lewis
Washington, DC
Global Counsel - Advertising and Promotions
Mylan Inc.
Washington, DC