FDA asks for stakeholder feedback on using MDUFA V user fees to advance real-world evidence

As part of the recently reauthorized MDUFA V, the FDA is seeking public comment on how they should use medical device user fees, not related to the National Evaluation System for health Technology (NEST), that are distributed to external organization(s) to support real-world evidence for premarket submissions. 

In late 2022, several US FDA user fee reauthorizations took place, including the fifth reauthorization of the Medical Device User Fee Amendments (MDUFA V). In MDUFA V, the FDA outlined several commitments they would carry out over the next 5 years as part of their pledge for the continued development of real-world data and evidence (RWD/RWE) methods and policies in medical device regulatory decision-making.  

In this new announcement, the FDA explained that they are meeting the requirements of one of these commitments by seeking feedback from stakeholders on how the fees they collect under MDUFA V are distributed to external organizations to support premarket RWE. As noted by the FDA, the comments sought specifically relate to how the fees will be used to fund external parties other than the National Evaluation System for health Technology (NEST), which it currently funds to advance RWE methodological and policy activities. 

In announcing the policy, the FDA stated, “The FDA remains committed to work collaboratively to advance the development of RWD and use of RWE to evaluate device performance.” 

Public comments are being sought related to the question ‘How should the FDA use device user fee funding that may be distributed to an external organization other than NEST?’, and stakeholders should provide their comments via the docket FDA-2023-N-0156.