Stakeholders Back Draft MDUFA VI Letter Despite Staffing, RWE Concerns

Industry, patient, and consumer stakeholders generally support FDA's draft medical device user-fee agreement (MDUFA VI) letter, viewing it as a step toward enhancing review consistency, patient engagement, digital health oversight, and breakthrough device coordination despite some concerns about staffing and real-world evidence use.

This Wire brief sits within Fusion42's coverage of Medtech, and 2 sources have reported it.