The EveryLife Foundation for Rare Diseases has submitted written comment to the FDA regarding the initiation of the Reauthorization of Medical Device User Fee Agreements (MDUFA) for fiscal years 2028 through 2032 (MDUFA VI). The work of FDA Center for Devices and Radiological Health (CDRH), supported by MDUFA commitments, enables innovation in diagnostic testing and medical advances that can address the significant unmet needs of the 10 percent of Americans living with rare diseases.
What is MDUFA?
Device user fees were established in 2002 by the Medical Device User Fee and Modernization Act. Under the user fee system, medical device companies pay fees to the FDA when they register their establishments and list their devices with the agency, whenever they submit an application or a notification to market a new medical device. These fees are used to 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 market.
MDUFA has been reauthorized four times since 2002, with MDUFA V set to expire in September of 2027. The FDA is currently meeting with the public, including patient and consumer stakeholders, to finalize MDUFA VI.
What did we advocate for?
- The close integration of CDRH in activities of the Rare Disease Innovation Hub, including innovations in approaches to:
- Drug/device combination product consultation and review
- Post-market efficacy and safety monitoring
- Consultation as additional clinical areas for TAP Pilot program expansion are explored
- The piloting of the formal inclusion of patient advocacy organizations within collaborations formed through the CDRH Innovation Activities, including the integration of patient preference information.
