The FDA Intends to Withdraw Final Guidance

The FDA intends to withdraw final guidance: Effects of the COVID-19 Public Health Emergency on Formal Meetings and User Fee Applications.

If your email program has trouble displaying this email, view as a webpage. FDA Intends to Withdraw Final Guidance: Effects of the COVID-19 Public Health Emergency on Formal Meetings and User Fee Applications for Medical Devices--Questions and Answers (Revised) Today, the U.S. Food and Drug Administration (FDA) is announcing in the Federal Register, our intent to withdraw the guidance document entitled "Effects of the COVID-19 Public Health Emergency on Formal Meetings and User Fee Applications for Medical Devices--Questions and Answers (Revised)," which was issued in June 2020 (and updated December 2020). The FDA is withdrawing this guidance document in recognition that the conditions that created the need for these policies have evolved, such that these policies are no longer needed. The FDA has determined it is in the interest of the public health to return to pre-pandemic policies to facilitate more timely premarket review of innovative and potentially lifesaving devices. The withdrawal date is July 7, 2022. The FDA noted that we were considering withdrawing this final guidance in the May 2022 FDA's Center for Devices and Radiological Health's Continued Efforts to Return to Normal: Reopening for All Pre-Submissions FDA Voices article. Questions? If you have questions about this final guidance, contact the Division of Industry and Consumer Education.

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