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: No New Submission Reviews, And More" - Medtech Insight, 3 October, 2013..) Of the 101 submissions that piled up at the agency during the period, 33 were PMAs and 68 were 510(k)s.

CDRH has been working on a plan to address the backlog since the government reopened Oct. 17. (See Also see "Addressing The Backlog: Government Shutdown Ends, Now FDA Has To Catch Up" - Medtech Insight, 18 October, 2013..)

All user fee-funded device submissions that were submitted between Oct. 1 and Oct. 16 were assigned a receipt date of Oct. 17, CDRH explained in an Oct. 24 email sent to device firms and trade groups, and obtained by “The Gray Sheet.”

FDA says it remains accountable to meet the MDUFA III review goals for these submissions, based on the receipt date of Oct. 17, provided all applicable fees have been paid as required. As of Oct. 18, CDRH had logged all of the submissions into its system.

CDRH noted that it continued during the shutdown to log in and review all other types of non-user-fee funded submissions, such as IDEs, per its standard procedures.

Expecting More Submissions

“We anticipate receiving more submissions than usual this week and next – due to companies that may have withheld their submissions during the shutdown or may have been waiting on small business designations,” CDRH said in the Oct. 24 email.

The device center says it plans to log in new submissions as quickly as possible.

“Although we don’t know what those numbers will be, we are prepared to log in as many submissions as possible each day. If we are unable to log in a submission on the same day it was received, we will log it in the following business day. We plan to continue this process until we return to normal submission levels,” the email said.

FDA said it received fewer submissions during the 16-day shutdown than it would normally receive during that period of time.

“We expect that some companies may have held back their submissions during the shutdown,” Peper Long, CDRH associate director for external relations, told “The Gray Sheet.”

Industry seems confident that FDA will continue to meet its review commitments, despite the backlog.

Mark Leahey, president and CEO of the Medical Device Manufacturers Association, said, “MDMA appreciates FDA's efforts during the partial government shutdown and we remain confident that they will be able to meet the MDUFA III commitments and milestones.”

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

More from Regulation

More from Policy & Regulation