Shutdown: No New Submissions, But Reviews, Meetings to Continue

October 8, 2013
CDRH won’t accept new PMAs or 510(k)s until the partial government shutdown ends. With Congress unable to agree on a fiscal 2014 government-funding plan, the FDA has limited its operations to “emergency work” and enforcement activities, freezing regulatory submissions for fiscal 2014 supported by new 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 a notice to industry Tuesday.
Devices & Diagnostics Letter