Out of EUA— FDA’s Guidance & Recommendations

In our webinar held last July about the FDA’s Emergency Use Authorization (“EUA”), presenter Jianlin Song predicted that, as we get closer to the end of the pandemic, the FDA would release guidelines to help the industrial players transition their products from the temporary EUA pathway to its traditional regulatory schemes. The guidelines are finally out—in December 2021, the FDA published two Draft Guidance Documents containing transition plans for medical devices that either issued EUAs or fall within any related enforcement policies to return to normal operations and foster compliance with the applicable regular policies. Public comments are to be submitted before March 23, 2022.

In the upcoming webinar she will review the agency’s recommendations in these two documents and discuss what companies and insurers should expect in the next few months.