We knew this would be happening at some time and it appears that it will next month – the EUA will end.

As the COVID-19 Crisis Returns to Pre-Pandemic Levels…

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)

The U.S. Food and Drug Administration (FDA) is announcing in the Federal Register, their 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 they 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?

We are monitoring this situation and will update you as we get more information.

In the interim, if you would like to discuss the FDA intent to withdraw final guidance document, please email us at: [email protected] and ref: Final Guidance Document- COVID-19.