FIRF RECOMPETE TO: #11: Premarket/Postmarket Services
Past New Requirement Updated
- Agency
-
Food and Drug Administration
Department of Health and Human Services
- Solicitation expected
- Estimated value
- $3,000,000 to $7,000,000
- Set-aside
- Total Small Business
Forecast facts
- Anticipated award
- NAICS code
- 561990 All Other Support Services
- Points of contact
-
- CDRH Acquisition Liaison cdhracquisitions@fda.hhs.gov
Forecast details come from HHS's procurement forecast. Agencies' dates and values are estimates.
About this forecast
The Food and Drug Administration is recompeting a task order for premarket and postmarket services supporting the Center for Devices and Radiological Health (CDRH) Registration and Listing Program, with solicitation estimated for release on September 1, 2026, and award targeted for March 1, 2027. The contractor will provide support services to approximately 31,000 medical device establishments annually, including answering inquiries about registration and listing requirements, assisting firms with electronic submission via the FDA Unified Registration and Listing System (FURLS) and Device Registration and Listing Module (DRLM), reviewing and generating routine reports and queries, correcting or entering registration and listing data in FURLS/DRLM and other FDA systems such as FACTS, and sending correspondence to stakeholders.
The contract is set aside for total small business under NAICS 561990 (All Other Support Services) with an estimated award value between $3 million and $7 million. Point of contact for this requirement is the FDA's CDRH Acquisitions mailbox at cdhracquisitions@fda.hhs.gov.
Forecast text
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.
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