Progress Tracker Update: Now Tracking Abbreviated and Special 510(k) Submissions

Today, the U.S. Food and Drug Administration (FDA) updated the progress tracker to enable the medical device industry to track the status of Abbreviated and Special 510(k) submissions.

The FDA developed both the Special and Abbreviated 510(k) Programs to facilitate the review of certain types of submissions subject to 510(k) requirements. The FDA offers online progress tracking to fulfill its Medical Device User Fee Act (MDUFA) commitments.

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Questions about the progress tracker?

If you have questions about this progress tracker, email ccp@fda.hhs.gov.