The FDA recently announced release of final transition guidance documents for medical diagnostic devices targeting COVID-19. The transition guidance documents are intended to guide COVID-19 diagnostic device manufactures as their devices transition from Emergency Use Authorizations (EUAs). Just over three hundred EUAs were issued for diagnostic devices during the COVID-19 pandemic. In the announcement, the FDA characterized the issuance of EUAs as “proactive steps to help facilitate the availability of critical medical devices, including in vitro diagnostic tests.” Draft versions of the guidance documents were made available for public comment in December 2021.
The FDA’s announcement follows the recent White House announcement that the COVID-19 Public Health Emergency is set to expire on May 11, 2023. Though the initial public health emergency announcement authorized use of EUAs for various COVID-related products, the end of the public health emergency does not automatically terminate the pending EUAs. Instead, the Department of Health & Human Services (HHS) will publish notice of termination of each EUA declaration 180 days in advance. Notice will publish in the Federal Register.
The final transition guidance documents clarify recommendations for labeling, post-EUA disposal of diagnostic devices, and use of real-world evidence in FDA marketing submissions. Additionally, the transition guidance documents clarify the relationship between the transition period guidance and the previous COVID-19 guidance from the FDA (i.e., those found in List 1 of the Transition Plan, including guidance on digital pathology, imaging systems, non-invasive fetal and maternal monitoring, and other technologies).
Industry groups, for example AdvaMed and MITA, had previously expressed approval via public comment of the 180-day transition period proposed by the draft guidelines.
The FDA has encouraged device manufacturers that plan to seek marketing authorization to begin working on a marketing submission soon.
The FDA will be holding a webinar to answer questions about the transition on April 18, 2023.