FDA will launch pre-market submission tracker pilot in January 2021

The US Food and Drug Administration (FDA) has announced that it will be carrying out a ‘soft launch’ of a real-time tracking system for pre-market submissions in January 2021.

FDA committed to providing a submission tracker in its MDUFA commitments to the medical device industry, so during the January 2021 soft launch, the submission’s Official Correspondent will be able to navigate through the progress tracker, allowing them to see the status of their Traditional 510(k) submission. The FDA will ask the Official Correspondent to provide feedback regarding the usability of the tracker, such as the ease of navigation, utility of the information provided, and tracker functions and features. FDA expects the pilot scheme to run for at least 90 days.

FDA explains that the progress tracker is the first feature of a larger platform to help FDA collaborate with the medical device industry regarding the status of pending premarket device submissions.

In January 2021, FDA will update the tracker webpage to announce details on how to submit a request to participate in the soft launch. To ensure that you are notified about the announcement, the FDA recommends that you subscribe to the CDRH Industry email list.