Medical Device User Fee (MDUFA IV) Highlight Videos

In preparation for the October 27, 2020 public meeting on the reauthorization of the Medical Device User Fee Amendments for fiscal years 2023 through 2027 (MDUFA V), the FDA’s Center for Devices and Radiological Health (CDRH) prepared a video series highlighting the Center’s accomplishments in meeting and going beyond its MDUFA IV commitments.

Specifically, these videos highlight the FDA’s efforts and accomplishments in:

Meeting its performance goals under the MDUFA IV agreement.
Building a sustainable infrastructure for efficient, consistent, transparent, and high-quality regulation of devices throughout the total product lifecycle.
Accessing and using real-world and postmarket data in the regulatory decision-making process.
Advancing patient engagement and the regulatory science of patient input.
Advancing the smart oversight of digital health technologies in ways that support innovation, balance innovation and safety, and show promise as a potential blueprint for future regulatory approaches to emerging technologies.

Watch the videos

MDUFA V Public Meeting

The agenda for the MDUFA V public meeting is now available. As a reminder, the October 27th public meeting will be held by webcast only beginning at 9:00 a.m., Eastern Time.