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*RCPM: Contract Continuation and Accelerated Start-up

Forecast

Federal

Contract Overview

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AI Contract Overview

The Medical Device User Fee Amendments provide a statutory framework allowing the FDA to collect user fees from manufacturers to enhance the resources, transparency, and predictability of medical device application reviews. To support these goals, the Center for Devices and Radiological Health implemented the Insight Time Reporting platform to track staff workload and capacity through specific submission tracking numbers. Under the draft agreement for MDUFA VI, which spans from October 1, 2027, to September 30, 2032, the FDA is committed to further developing its Resource Capacity and Planning Management capabilities. A primary requirement of this cycle is the publication of an RCPM Implementation Plan by March 31, 2029. Consequently, the FDA is seeking a contract to assess current RCPM capabilities across the MDUFA program components during the remainder of the MDUFA V period.

General Info

FDA seeks a contract to assess RCPM capabilities for the MDUFA VI cycle.

Agency

Food and Drug Administration → Food And Drug Administration

NAICS

541611 - Administrative Management and General Management Consulting Services

Place of Performance

USA

Set-Aside

NONE

Documents

No documents available

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Organization & Contact Information

AgencyFood and Drug Administration → Food And Drug Administration

Contacts2 people available

OfficeN/A

Organization / AgencyFood and Drug Administration → Food And Drug Administration

Office AddressN/A

Contacts

Cdrh Acquisition Liaison

contact@example.gov

To Be Determined To Be DeterminedContracting Officer

Full Description

The Medical Device User Fee Amendments (MDUFA) provides a statutory framework for increasing FDA resources available to conduct the process for the review of medical device applications through the collection of user fees from medical device manufacturers as a condition for improving medical device review performance, transparency, and predictability. Since the beginning of MDUFA IV (October 1, 2017), the MDUFA Commitment Letter has included a requirement to perform "complete time reporting such that data from time reporting can be used to conduct workload analysis and capacity planning." Based on this commitment, CDRH adopted FDA's Insight Time Reporting (ITR) activity-based time reporting platform for the MDUFA program, and implemented CDRH's specific version of ITR in early 2020. CDRH's implementation of ITR linked the activity codes to CDRH's Center Tracking System (CTS) so that staff can log their time to specific submission tracking numbers. The draft agreement for MDUFA VI builds on this capability by committing FDA to further developing its RCPM capabilities during the next authorization cycle of October 1, 2027 through September 30, 2032. FDA expects Congress to reauthorize MDUFA prior to the expiration of its current authority on September 30, 2027. A key deliverable of the MDUFA VI agreement is to publish a RCPM Implementation Plan by March 31, 2029.One of the first important responsibilities of the RCPM WG is to provide guidance and technical oversight for a contract to assess the RCPM capabilities of CDRH and other MDUFA program components during the remaining authorization period of MDUFA V.