03/27/2023

FDA Issues Final Guidances for COVID-19 Medical Device Transition Plans

Source: AAHomecare Alert 3/24/23

As we shared in this week’s AAH Insider, the Food and Drug Administration (FDA) is ending the COVID-19 Emergency Use Authorization (EUA) devices on Nov. 7, 2023. Under this COVID-19 ‘umbrella’ EUA, the FDA allowed for certain ventilators, PAP devices, RADs, and other respiratory devices and related accessories to be used by patients that did not go through the formal FDA clearance.

This morning, the FDA issued two finalized guidance documents for manufacturers with general recommendations and expectations for transitioning back to normal operations:

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

In their announcement, FDA notes that there will be a 180-day transition period for impacted devices to help avoid disruption in device supply and help ensure an orderly and transparent transition.  Specific information on the scope and the timeline for the transition period can be found in each guidance.

On Apr. 18, 2023, the FDA will host a webinar for stakeholders interested in learning more about the guidances.

For More Information

• Complete Announcement from FDA’s Center for Devices & Radiological Health (Mar. 24, 2023)
• Final Transition Guidance Document
• Federal Register Notice on the EUA Transition Guidance (to be published Mar. 27, 2023)