The U.S. Food & Drug Administration (FDA) has released guidance documents related to the upcoming end of the COVID-19 Emergency Use Authorization (EUA) process.
In a March 24 bulletin to stakeholders, the American Association for Homecare (AAHomecare) noted that the FDA’s EUA for devices will end Nov. 7, 2023. “Under this COVID-19 ‘umbrella’ EUA,” the bulletin explained, “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.”
But in late March, the FDA released two finalized guidance documents aimed at manufacturers “with general recommendations and expectations for transitioning back to normal operations,” AAHomecare said.
The two documents are the 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 Related to Coronavirus Disease 2019 (COVID-19).
The FDA said the documents “outline the FDA’s general recommendations to transition from certain policies adopted and operations implemented during the COVID-19 pandemic to normal operations.” The agency also announced a 180-day transition period for the devices involved “to help avoid disruption in device supply and help ensure an orderly and transparent transition,” AAHomecare said.
The FDA is hosting a Webinar on April 18, 1 p.m. to 2:30 p.m. Eastern time, to provide further information about the guidances. Among the topics covered will be preparing manufacturers and other stakeholders for an orderly and transparent transition from COVID-19 policies to normal operations; recommendations for creating a marketing submission, plus the timeline for the submission; and fielding questions about the guidances and COVID-19 transition plans.
Pre-registration for the Webinar is not required. Go to the FDA page to join the Zoom videoconference.
The Emergency Use Authorization was in response to pandemic-related issues with the supply chain for certain medical devices, the FDA said, noting, “The demand for certain devices has exceeded available supply.
“As such, since the beginning of the COVID-19 pandemic, FDA took a number of proactive steps to help facilitate the availability of critical medical devices, including issuing Emergency Use Authorizations, which has enabled access to medical devices to help diagnose, treat, or prevent COVID-19. In addition, FDA issued guidances to help expand the availability of certain devices to help patients, healthcare providers, and other healthcare professionals access devices for COVID-19-related uses.”
That included allowing “the manufacturing of devices by non-traditional manufacturers to address supply issues and the distribution and use of capital or reusable equipment that fall within enforcement policies issued during the COVID-19 Public Health Emergency (PHE).”
With the end of the EUA process upcoming, the FDA said its guidance documents can “provide recommendations to manufacturers that may or may not want to continue to distribute certain medical devices after the PHE declaration expires and certain enforcement policies issued during the COVID-19 PHE are no longer in effect, or the relevant EUA declaration related to COVID-19 terminates.”