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Government Shutdown Causes Backlog Of 100 Device Submissions, With More Expected

CDRH says it received 101 device submissions during the two-week government shutdown, and has logged them into its system. The center also expects an increased number of submissions in the coming weeks, but remains confident it will meet its MDUFA review timelines.

The device center announced Oct. 24 that it received 101 device submissions during the 16-day government shutdown, and expects even more in the coming weeks from companies that may have avoided submitting due to the shutdown.

During the shutdown, FDA was not allowed to formally accept or log in any user-fee funded device submissions, including PMAs and 510(k)s. (See Also see "Shutdown Realities At FDA:...

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