FDA Issues Draft Guidances on Transition Plans for COVID-19 Related Medical Devices

"Since the start of the pandemic, the FDA has issued emergency use authorization for more than 800 devices that are essential to protecting the public health, including COVID-19 tests and PPE, and facilitated access to many more through its flexible policies. While we continue working to defeat this virus, the agency is seeking early feedback on a plan to assist stakeholders, including industry, health care professionals, and patients, with a smooth transition away from these temporary emergency measures to the eventual resumption of normal operations." -- Jeff Shuren, M.D., J.D., director of the FDA's Center for Devices and Radiological Health

Today, the U.S. Food and Drug Administration (FDA) issued two draft guidances:

• Transition Plan for Medical Devices Issued Emergency Use Authorizations (EUAs) During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency; Draft Guidance
• Transition Plan for Medical Devices That Fall Within Enforcement Policies Issued During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency; Draft Guidance

The draft guidances, when finalized, are intended to:

• Help prepare manufacturers and other stakeholders for the orderly and transparent transition to the eventual resumption of normal operations
• Foster compliance with applicable requirements under the Federal Food, Drug, and Cosmetic Act (FD&C Act) and implementing regulations when the relevant EUA declarations and COVID-19-related enforcement policies cease to be in effect
• Help avoid supply disruptions
• Facilitate continued patient and health care provider access to medical devices needed in the prevention, treatment, and diagnosis of COVID-19 as manufacturers take steps to transition their devices through traditional submission pathways
• Describe recommendations regarding submitting a marketing submission and the timeline for doing so
• Provide examples to illustrate the transition policies and exemplify the 180-day transition period timeline

Although these draft guidances are not for implementation at this time, manufacturers are encouraged to pursue any required marketing submissions through the appropriate regulatory pathway (for example, 510(k), De Novo, PMA) during the public health emergency if they plan to continue distribution after the public health emergency ends or the relevant EUA declaration is terminated.

Upcoming webinar on the draft guidances

On February 22, 2022, the FDA will host a webinar for industry and others interested in learning more about the draft guidances.

Submit comments on the draft guidances

These draft guidances will be open for public comments for 90 days at www.regulations.gov until March 23, 2022, under the docket numbers listed below. The FDA encourages all stakeholders to comment on the specific topics listed in the notices of availability and on the draft guidance web pages:

• Docket number FDA-2021-D-1149 for 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-1118 for Transition Plan for Medical Devices That Fall Within Enforcement Policies Issued During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency; Draft Guidance

Questions?

If you have questions about these draft guidances, contact the Division of Industry and Consumer Education.