The U.S. Food and Drug Administration (FDA) aims to protect and promote the public health by ensuring the safety and effectiveness of medical devices, assuring that patients have timely access to them, and advancing medical device innovation. Medical device user fees help the FDA increase the efficiency of regulatory processes with a goal of reducing the time it takes to bring safe and effective medical devices to the United States market.

Consistent with its commitments 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. The FDA 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 the FDA’s implementation of MDUFA V, the agency is announcing the opportunity for stakeholders to submit public comments on how we should use any portion of the user fee funding that may be distributed to external organization(s) other than NEST to support premarket RWE. This announcement is issued consistent with the following remit from MDUFA V:

FDA will publish a document requesting public comment on how the FDA should use any portion of the user fee funding that may be distributed to any external organization(s) other than NEST to support premarket RWE.

Request for Public Comment

The FDA has opened a public docket for stakeholders to offer specific comments on the following question:

How should the FDA use device user fee funding that may be distributed to an external organization other than NEST?

Please submit all public comments to the docket (FDA-2023-N-0156, available at Regulations.gov).

The public comment period is 60 days and will end on 03-20-2023.

Background: FDA, NEST, RWD and RWE

FDA and NEST

Since the Medical Device User Fee and Modernization Act (MDUFMA) was enacted in 2002, it has been reauthorized five times. Under the Medical Device User Fee Amendments of 2017 (MDUFA IV), the FDA and stakeholders committed to a shared goal of advancing RWE, which included supporting the establishment of NEST and strengthening the FDA’s RWE expertise.

The NEST Coordinating Center (NESTcc), an initiative of the Medical Device Innovation Consortium (MDIC), was created to develop the NEST organizational framework and catalyze evidence generation in the medical device ecosystem. Establishing NEST was one of the FDA’s Center for Devices and Radiological Health’s (CDRH's) 2016-2017 strategic priorities. The FDA is an active participant in NEST, building on work the FDA started in 2012. The FDA has met the MDUFA IV commitments to advance RWE by expanding internal expertise and providing funding to the NESTcc.

Real-World Data and Real-World Evidence

RWD and RWE have an increasing role in health care decisions and as part of the clinical evidence the FDA uses to make regulatory decisions.

Real-world data are the data relating to patient health status and/or the delivery of health care routinely collected from a variety of sources. RWD can come from a number of sources, such as: electronic health records, claims and billing activities and product and disease registries.

Real-world evidence is the clinical evidence regarding the usage and potential benefits, or risks of a medical product derived from analysis of RWD. RWE can be generated by different study designs or analyses, including but not limited to, randomized trials, including large simple trials, pragmatic trials, and observational studies.

Consistent with its commitments under the MDUFA V, the FDA will use user fee revenue for the continued development of RWD and RWE methods and policies to advance regulatory acceptance for premarket submissions.

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

Questions

For general questions about the FDA’s user-fee funding, contact the Division of Industry and Consumer Education.