*RCPM: Contract Continuation and Accelerated Start-up

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.

Estimated value

>= $700K and < $1.5M

Est. solicitation date

Jul 1, 2026

Anticipated award

Jan 1, 2027