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  5. MDUFA IV and Beyond – Video Reports
  1. Medical Device User Fee Amendments (MDUFA)

MDUFA IV and Beyond – Video Reports

The Medical Device User Fee Amendments of 2017 (MDUFA IV), covers the period from October 1, 2017 through September 30, 2022. The FDA’s Center for Devices and Radiological Health (CDRH) prepared a video series highlighting the significant progress the Center has made to date with implementing and going beyond the MDUFA IV commitments. These accomplishments help to advance the Center’s mission to protect and promote the public health, and to assure that patients and providers have timely and continued access to safe, effective, and high-quality medical devices.

Specifically, these videos highlight the FDA’s efforts and accomplishments over the first three years of the MDUFA IV agreement:

  • Meeting, and going beyond 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.

As we begin to prepare for the fifth cycle of user fee negotiations (MDUFA V), the FDA will hold a public meeting on October 27, 2020 to receive public feedback on the reauthorization of the medical device user fee amendment. For more information on the MDUFA V meeting, see Virtual Public Meeting - Medical Device User Fee Amendments for Fiscal Years 2023 Through 2027.

MDUFA IV Highlights and Accomplishments

MDUFA IV and Beyond

Medical Device User Fee Amendments of 2017 (MDUFA IV) Performance Update

Building a Sustainable Infrastructure

Accessing and Using Real-World and Postmarket Data for Regulatory Decision-Making

MDUFA IV Commitment: Patient Engagement & the Science of Patient Input

Digital Health – A Program Update

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