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FDA Launches New Premarket Submissions Tracker

The U.S. Food and Drug Administration (FDA) has now made available an online platform for uploading and tracking the progress of premarket submissions for medical devices.

According to a posting on the FDA’s website, the updated Customer Collaboration Portal went live in mid-July and now allows medical device manufacturers to upload medical device submission files for 510(k) and De Novo applications in both eSTAR and eCOPY formats. This eliminates the need for device manufacturers to create and mail compact discs or flash drives to the FDA.

Once files have been uploaded, a manufacturer’s designated “Official Correspondent” can then access the Portal to track the progress of their submission.

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The updated Customer Collaboration Portal is in its trial phase, and the FDA is actively soliciting feedback on its use from submitters.

Read more details on the FDA’s new premarket submissions tracker.

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