FIRF RECOMPETE TO: #11: Premarket/Postmarket Services

FIRF RECOMPETE TO: #11: Premarket/Postmarket Services Medical device establishments pay the annual registration user fee and submit their registration and listing information electronically via the FDA Unified Registration and Listing System (FURLS)/Device Registration and Listing Module (DRLM). Each year approximately 31,000 medical device establishments contact the CDRH Registration and Listing Helpdesk for assistance with complying with this requirement. The purpose of this task order is to obtain Contractor services for the CDRH Registration and Listing Program. These services include answering general inquiries about registration and listing requirements; helping firms with submitting their registration and listing information electronically; reviewing reports; running routine reports/queries; correcting and/or entering registration and listing data entered in FURLS/DRLM and other FDA systems, such as FACTS; and e-mailing correspondence to stakeholders.