YouTube Facebook LinkedIn Google+ Twitter Xingrss  

FDA Plans to Introduce Web Portal for Tracking Device Submissions


August 15, 2014 | The FDA's Center for Devices and Radiological Health (CDRH), the division responsible for approving new medical devices — which include, in the FDA's definition, molecular diagnostic tests — is piloting a program that would let companies track the progress of devices submitted for premarket approval through the agency's review process. The CDRH Submission Tracker, which is being designed with guidance from trade associations, will feature the current status of the review clock associated with a device's 510(k) submission, and contact information for the FDA members assigned to the review. Regulatory Focus
Click here to login and leave a comment.  

0 Comments

Add Comment

Text Only 2000 character limit

Page 1 of 1


For reprints and/or copyright permission, please contact  Terry Manning, 781.972.1349 , tmanning@healthtech.com.