FDA Activities are limited due to government shutdown

FDA activities are limited from October 1, 2013, and continuing until the date of enactment of  FY 2014 appropriation.

Drug Registration

Even though the activities are limited FDA is accepting SPL submission for Drug establishment registration, Drug listing and NDC Labeler code request. But the NDC Labeler code assignment may be delayed.

Food Facility Registration.

The food facility registration and prior notice modules are working fine during the lapse period

Medical Device Registration

FDA is not collecting the Establishment registration fee for the year 2014, which may affect the registration and listing of new medical device and renewal of existing registrations.

FDA is not accepting 2014 medical device user fees for regulatory submissions like 510 (k) for 2014 fiscal year which may affect the new submission to FDA.

FDA Biennial Registration Renewal

The extended time for FDA Biennial Registration Renewal will end by Jan 31, 2013. After that FDA may suspend the registration.