Transition Plan for Medical Devices Issued FDA EUAs

January 6, 2022

To help fight the pandemic, the FDA has been issuing EUAs and exercising enforcement discretion for medical devices needed to diagnose, treat, or prevent COVID-19. Last month, the agency issued two draft guidances related to transition plans to regular compliance for COVID-19 related medical devices that fall under EUAs or Agency Enforcement Policies that have been used to ease regulatory requirements. The two draft guidance documents are provided below.

Transition Plan for Medical Devices Issued Emergency Use Authorizations (EUAs) During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency; Draft Guidance (Docket number FDA-2021-D-1149); and

Transition Plan for Medical Devices That Fall Within Enforcement Policies Issued During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency; Draft Guidance (Docket number FDA-2021-D-1118).

On February 22, 2022, the FDA will host a webinar to learn more about the draft guidances.

Among other things, the draft guidances, when finalized, will set forth similar processes and recommendations for manufacturers who have determined either to continue to distribute or to cease the marketing of their devices after the end of their EUA or FDA Enforcement Policy. In both cases, FDA proposes a transition period of not less than 180 days, though with different starting points.

These draft guidances will be open for public comments at www.regulations.gov until March 23, 2022 – (docket FDA-2021-D-1149 for the EUA Transition Draft Guidance and docket FDA-2021-D-1118 for the Enforcement Policy Transition Draft Guidance).