FDA Launches Progress Tracking Program for 510(k) Premarket Applications


By: Randolph Fillmore

September 7, 2021

Categories: AAMI News, Medical Device Manufacturers

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In the dark about the progress of your FDA 510(k) application? Wonder no more, as the agency just launched an application progress tracking program that takes the guesswork out of determining the status of a 510(k) premarket application.

The system uses a secure, web-based tracker displaying progress on a traditional 510(k) submission to the Center for Devices and Radiological Health (CDRH) for review. The progress tracker fulfills the promise FDA made in its Medical Device User Fee Act (MDUFA) commitments for developing and making available an easy-to-use industry dashboard that displays a 510(k) application’s status in “near real-time.”

The company’s Official Correspondent is the only one who can monitor the FDA’s progress online in a simple, concise format. When an Official Correspondent first tracks a submission online, FDA automatically emails a link for creating a login password. Soon after FDA starts its review, FDA will email the Official Correspondent regarding the submission’s status, official actions, and any requests.

Questions regarding the premarket submission’s progress tracker may be emailed to ccp@fda.hhs.gov.