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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
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