FDA Seeks Input on Advancing Use of Real-World Data and Evidence

By MedTech Intelligence Staff
January 21, 2023


• Categories: 04-Product Design & Development, 05-Quality/Regulatory

The FDA is seeking input from stakeholders on how it should use user fee funding for engaging with external organizations, other than the National Evaluation System for Health Technology (NEST), to support premarket Real-World Evidence.

Under the fifth reauthorization of the Medical Device User Fees Amendments (MDUFA V), a portion of the current user fee funding is used to support the National Evaluation System for Health Technology (NEST) premarket Real-World Evidence (RWE) activities. In its request for public comment, the FDA said that it remains committed to work collaboratively to advance the development of Real-World Data (RWD) and use of RWE to evaluate device performance.

As part of this commitment and the FDA’s implementation of MDUFA V, the agency is asking stakeholders to submit public comments on how it should use any portion of the user fee funding that may be distributed to external organizations—other than NEST—to support premarket RWE.

Stakeholders can submit public comments through regulations.gov under docket number FDA-2023-N-0156. The 60-day public comment period will end on March 20, 2023.

For more information see Guidance for Industry and Food and Drug Administration Staff: Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices.