On February 22, 2022, the US Food and Drug Administration (FDA) hosted a webinar detailing its current transition plans for medical devices marketed pursuant to either Emergency Use Authorization (EUA) or Enforcement Policies during the COVID-19 public health emergency (PHE). The primary purposes of the webinar were to help prepare manufacturers and other stakeholders for the upcoming transition back to normal operations, provide examples illustrating the transition policies, and outline the 180-day transition period timeline. Providers that may be affected are encouraged to be proactive and take steps to understand FDA’s proposed plan and become prepared to handle the upcoming transition.
The FDA’s transition plans and policies are laid out in two recent draft guidance documents, Transition Plan for Medical Devices Issued EUAs During the COVID-10 PHE (EUA Transition Plan) and Transition Plan for Medical Devices That Fall Within Enforcement Policies Issued During the COVID-19 PHE (Enforcement Policy Transition Plan), which are to be implemented with a focus on four key principles:
- an orderly, transparent transition with consistent FDA-manufacturer interactions,
- a risk-based approach to different types of devices,
- FDA action as necessary on a case-by-case basis, and
- continued patient and provider access to devices.
Devices subject to Transition Plan requirements are listed in the draft guidance by product code, which will be updated until finalized. The EUA Transition Plan does not apply to (i) devices for which EUAs have already been, or will be, revoked because their criteria were no longer met or because other circumstances make such revocation appropriate to protect the public health or safety, or (ii) good manufacturing practice deviations. Notably, the Enforcement Policy Transition Plan does not include diagnostic tests commercialized pursuant to FDA’s Policy for Diagnostic Tests for COVID-19.
As part of the 180-day transition period, the FDA has set out action recommendations for the return to normal operations under a multi-phased approach. Under the approach, some devices in certain conditions may be allowed to continue without an EUA. However, it appears that the FDA’s intent is for most devices previously authorized under an EUA to proceed under the standard pathways for FDA approval in order to continue distribution after the PHE. The FDA’s current transition plan is nuanced, and application of the many steps and exceptions can become complex rather quickly. Comments on the draft guidance documents must be submitted by March 23, 2022 for consideration by FDA.
For over 35 years, Wachler & Associates has represented healthcare providers and suppliers nationwide in a variety of health law matters, and our attorneys can assist providers and suppliers in understanding the healthcare regulatory landscape. If you or your healthcare entity has any questions pertaining to healthcare compliance, please contact an experienced healthcare attorney at 248-544-0888 or wapc@wachler.com.