FDA launches online 510(k) submission tracker

2019 02 13 19 24 5396 Fda Logo V2 400

The U.S. Food and Drug Administration (FDA) has launched a 510(k) submission tracker to enable companies to follow their regulatory submissions to the agency.

The application shows the Center for Devices and Radiological Health's progress on reviewing 510(k) submissions, allowing companies' official FDA correspondents to communicate with the agency regarding the application, according to the agency.

The tracker is the first tool of a larger array the FDA is developing to help communicate 510(k) progress in real time, it said.

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