Effects of the COVID-19 Public Health Emergency on Formal Meetings and User Fee Applications for Medical Devices-Questions and Answers (Revised); Withdrawal of Guidance

Streszczenie

The Food and Drug Administration (FDA or Agency) is announcing the withdrawal of 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). 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.