FDA seeks comments on transition plans for emergency use devices after pandemic abates

The Food and Drug Administration (FDA) is requesting stakeholder comments on published guidance documents describing the regulatory requirements for devices authorized under the emergency use authorization (EUA) process and those under temporary FDA policies implementing specific enforcement discretion during the pandemic (Enforcement Policy Devices) once the Public Health Emergency for COVID-19 ends.

These guidance documents are of interest to manufacturers that developed and produced new devices or modified legally marketed devices specifically in response to the pandemic to help diagnose, cure, treat, or mitigate the symptoms of COVID-19. Both EUAs and FDA’s enforcement policies are temporary and designed to terminate once the emergency period ends, and at that time, any device that received an EUA or was developed, manufactured, labeled, and distributed in accordance with FDA’s enforcement policies will lose any marketing authorization or enforcement discretion. The Transition Plan Guidances will help device manufacturers prepare for the end of the emergency period and continue to commercialize devices necessary for the long-term response to COVID-19.

The Transition Plan Guidances establish similar transition frameworks for EUA and Enforcement Policy Devices, each with a notice to manufacturers that the transition is beginning followed by a specific period in which manufacturers will need to prepare and submit applications for appropriate marketing authorization. Both Transition Plan Guidances state that distribution of an EUA or Enforcement Policy Device must be discontinued if the manufacturer does not submit, and FDA has not accepted, a marketing submission by the time the designated transition period ends. Of course, manufacturers must also comply with all applicable device regulations - including registration and listing, quality system requirements, unique device identifier (UDI), and other labeling requirements - once the transition period ends. EUA and Enforcement Policy Devices that are class I or otherwise exempt from premarket notification requirements do not need to comply with the marketing submission requirements of the Transition Plan Guidances.

Importantly, the enforcement policy Transition Plan Guidance specifically excludes in vitro diagnostic tests for COVID-19, so any manufacturer of a COVID-19 test must follow the EUA Transition Plan Guidance.

In both guidances, FDA states that the agency will announce the start of the transition period for EUA and Enforcement Policy Devices in the Federal Register, and the EUAs and enforcement policies will terminate 180 days later. Manufacturers will need to prepare substantial marketing submissions, including new information requested by FDA in the Transition Plan Guidances, and in some cases implement appropriate systems and controls to ensure compliance with applicable device regulations by the end of such period.

FDA is currently accepting public comments on the Transition Plan Guidances, and it has scheduled a webinar for stakeholders on the plans for February 22, 2022. Comments must be submitted by March 23, 2022.

Read the EUA guidance and submit comments: https://www.fda.gov/regulatory-information/search-fda-guidance-documents...

Read the Enforcement Policy Devices guidance and submit comments: https://www.fda.gov/regulatory-information/search-fda-guidance-documents...

Read more from the National Law Review: https://www.natlawreview.com/article/fda-issues-draft-device-guidance-pr...