Government Shutdown Causes Backlog Of 100 Device Submissions, With More Expected-thegraysheet: 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.Of the 101 submissions that piled up at the agency during the period, 33 were PMAs and 58 were 510(k)s.
