FDA warns companies over pre-amendments devices

08/17/2009 | Medical Devices Today

The FDA's Center for Devices and Radiological Health is receiving submissions of safety and effectiveness data for 25 types of medical devices that are classified as pre-amendments products. The agency plans to review the documents and then publish them online, an agency spokeswoman said. The FDA's device unit could file an injunction or take other legal actions if the companies fail to submit the necessary documents.

View Full Article in:

Medical Devices Today

Published in Brief:

SmartBrief Job Listings for Health Care

Job Title Company Location
Director, Corporate Counsel - Regulatory Law
Tarrytown, NY
ISHN - Chief Compliance Officer
Mountain States Health Alliance
Johnson City, TN
Active Implantable Medical Device (AIMD) Product Expert
Nationwide, SL_Nationwide
Finance Manager - ENT
Jacksonville, FL
Consumer Directed Health Plan (CDH) Product Offering Manager
Blue Cross Blue Shield MA
Quincy, MA