US FDA medical device reviewers have about three month's worth of funding to support ongoing activities during the the partial government shutdown, Commissioner Scott Gottlieb disclosed on Twitter.
Medical device submissions made prior to the Dec. 22 start of the shutdown can be reviewed during the lapse period as long as "carryover" user fee funds remain available. Up until now, it has not been known how much time that gives the device center to continue these reviews.
"We’re still working through the final numbers but we have ~3 months of runway on the medical device side," Gottlieb tweeted Jan. 14.
That is longer than the five weeks the agency estimates it has left for drug user-fee funds. Gottlieb says it has slowed the burn rate for drug reviews by deferring overhead costs and shifting money to salaries at its drug and biologic centers.
The commissioner confirmed on Twitter that the agency is taking similar steps at the device center to "extend the runway" of carryover MDUFA user fees.
But Gottlieb tweeted this weekend that the agency is "closely evaluating when we will cross a threshold, beyond which, we have to declare that we will not be able to meet medical product user fee goals for 2019."
FDA remains unable to accept any new user-fee-linked submissions, including PMAs and 510(k)s, during the funding lapse. (Also see "As US FDA Shutdown Continues, What Will Be The Cost Of Not Spending?" - Medtech Insight, 2 Jan, 2019.) In addition to continuing pre-shutdown reviews, it can also perform various actions deemed necessary to support public health.
On Jan. 14, the agency disclosed that it will be re-starting inspections of "high-risk" product facilities this week with mostly unpaid inspectors. The emphasis is on inspecting food facilities, but Gottlieb said that high-risk medical product facilities will also be included in the restarted inspections.
The partial government shutdown, now the longest in US history, is entering its 25th day.
From the editors of The Gray Sheet