CDRH Updates Portal for Tracking Premarket Submissions

The FDA’s Center for Diagnostic and Radiological Health has added new functions to its portal where device sponsors can send in and track their premarket submissions.

The portal has two basic functions — for voluntary online submissions of original 510(k) and De Novo submissions and for tracking progress of 510(k) submissions.

The updated portal now allows official correspondents to add more users to view the status of 510(k) submissions and to filter and sort submissions.

In addition, the portal now features an expanded help section with common questions and answers, and an explanation of the new functions.