Medtech Insight

FDA Online Tracker Now Accepting Premarket Submissions

03 Aug 2022

The US FDA is now allowing users to submit 510(k), PMA, and other premarket applications through its Customer Collaborations Portal, which previously only allowed users to track submissions.

FDA Approved Screen — • Source: Shutterstock

The Food and Drug Administration’s Customer Collaborations Portal (CCP), an online platform for tracking traditional 510(k) submissions to the agency, has now been updated to allow users to submit applications.

Prior to the update, the CCP could only be used to track traditional 510(k) submissions that had been physically shipped...