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FDA Releases Medical Devices Draft Guidance for Review

“The Transition Plan for Medical Devices Issued Emergency Use Authorizations During the Coronavirus Disease 2019 Public Health Emergency” guidance is now available for review.

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To provide a clear policy for all stakeholders and FDA staff, the agency has issued the guidance to describe its general recommendations for this transition process with respect to devices issued EUAs during the COVID-19 PHE, including recommendations regarding submitting a marketing submission, as applicable, and taking other actions with respect to these devices.

Specifically, the draft guidance applies to devices that have been issued EUA under section 564 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360bbb-3) on the basis of a device-related COVID-19 EUA declaration. The draft guidance does not apply to devices for which FDA has revoked the EUA under section 564(g)(2)(B)-(C) of the FD&C Act because the criteria under section 564(c) of the FD&C Act were no longer met or because other circumstances made such revocation appropriate to protect the public health or safety.

The FDA is concurrently issuing a companion guidance to describe its recommendations for transitioning devices that fall within enforcement policies issued during the COVID-19 PHE.

New food packaging & processing solutions, all at PACK EXPO in Chicago
Experience the cutting edge of food packaging and processing innovation at PACK EXPO International this November. See machinery and equipment in action, discover new technologies, and learn sustainable solutions from experts, all in one place.
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New food packaging & processing solutions, all at PACK EXPO in Chicago
Explore new technology from hundreds of life sciences suppliers.
At PACK EXPO International, you’ll find innovations from hundreds of exhibitors that specialize in pharmaceuticals, biologics, nutraceuticals, medical devices and more. No other show delivers as many solutions to keep your products safe and effective.
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Explore new technology from hundreds of life sciences suppliers.