CDRH Playing Catch-Up On Device Reviews After Shutdown

The FDA has fallen behind on its medical device review process as a result of the 16-day partial shutdown of the federal government last month.

Bloomberg BNA reported this week that the agency's Center for Devices and Radiological Health (CDRH) is extending its deadlines for meeting review goals because the shutdown prevented from accepting new applications. The agency "was unable to process 100 device company submissions that it received during" the furlough, the report said. 

"Any fee-paying submission submitted [during the shutdown] will be assigned a receipt date of Oct. 17, the date the government reopened," the report said. "These submissions include 510(k) premarket notifications and premarket approval applications."

Adding to the crunch, the agency is expected to receive “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,” according to the report. 

For some companies, the delay could be up to three weeks, RAPS reported. 

About half of the agency's staff was furloughed during the shutdown. The agency was able to carry out a limited review functions during shutdown, funded by previously collected fees, Bloomberg BNA said.

But the FDA could not accept user fees for the next fiscal year during the shutdown. "With respect to medical product user fees, during the lapse period, FDA will not have legal authority to accept user fees assessed for FY 2014 until an FY 2014 appropriation for FDA is enacted," the agency said in an Oct. 1 update.

The upshot was that the agency could not accept any regulatory submissions for the next fiscal year "that require a fee payment and that are submitted during the lapse period."