Independent Assessment of MDUFA IV Commitments Now Available

The FDA met the relevant commitments for the program areas specified for the independent assessment overall.

If your email program has trouble displaying this email, view as a webpage. Independent Assessment of FDA's MDUFA IV Commitments Now Available The U.S. Food and Drug Administration (FDA) and device industry participated in a comprehensive, independent assessment of the FDA's premarket review of medical devices, as noted in the Medical Device User Fee Amendments of 2017 (MDUFA IV) Commitment Letter. The latest independent assessment report is now available. The independent assessment, conducted by consulting firm Booz Allen Hamilton, found that the FDA met the relevant commitments for the program areas as agreed upon in the Commitment Letter, with the exception of the Content of Premarket Submissions for Software Contained in a Medical Device draft guidance, which the FDA intends to issue within the 2021 calendar year. This report highlights our continued actions to meet our MDUFA IV commitments, despite a focus on responding to the COVID-19 pandemic and the additional strain on center resources from higher than projected non-COVID work. Read the Report Questions? If you have questions about the independent assessment, contact the Division of Industry and Consumer Education.

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