ARTICLE SUMMARY:
Shifting gears from pandemic response mode to a “new normal” has been a drawn-out experience for companies and FDA alike. It’s not over yet, but the agency has just finalized two guides that companies should follow to get their post-pandemic regulatory houses in order. Here are key takeaways from the documents.
FDA’s device center just published two long-anticipated guidance documents laying out how companies should transition any products they have been marketing under COVID-19 flexibilities to standard post-emergency regulatory status. One of the documents specifically addresses the transition process for devices with Emergency Use Authorizations (EUAs) for COVID and the other targets products leveraging various “enforcement discretion” policies tied to the official Public Health Emergency (PHE).
Companies should already have been preparing for the shift to non-emergency status based on (very similar) draft versions of these guidelines issued in late 2021. But the release of the final guidance documents solidifies exactly what manufacturers need to do to ensure they don’t run afoul of regulatory requirements when COVID-era policies expire. Here are our 7 key takeaways to help you understand the implications of the finalized guidance documents:
