The U.S. FDA has finalized two guides that outline general recommendations regarding the transition of medical device enforcement policies and Emergency Use Authorizations (EUA) established during the pandemic to normal operations
The two guidances—Transition Plan for Medical Devices That Fall Within Enforcement Policies Issued During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency and Transition Plan for Medical Devices Issued Emergency Use Authorizations (EUAs) Related to Coronavirus Disease 2019 (COVID-19)—include the FDA’s recommendations for:
- Developing a transition implementation plan,
- Submitting a marketing submission, and
- Taking other actions with respect to these devices.
The FDA is encouraging stakeholders to review the two final guidances; attend its upcoming webinar on guidances of COVID-19 transition plans for medical devices; and to reach out to the FDA if they have questions or concerns.
For manufacturers planning to seek marketing authorization for their devices, the FDA recommends beginning work on a marketing submission, including a transition implementation plan, as described in the guidances, the FDA says.
The FDA can use its Emergency Use Authorization (EUA) authority under section 564 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) to allow the use of unapproved medical products, or unapproved uses of approved medical products, to diagnose, treat, or prevent serious or life-threatening diseases when certain criteria are met, including that there are no adequate, approved, and available alternatives.
Before the FDA can issue an EUA, the U.S. Department of Health and Human Services (HHS) Secretary must make a declaration of an emergency, or a significant potential for an emergency and/or threat, justifying authorization of emergency use for a product.