The FDA has issued two final guidance documents intended to assist with transition plans for medical devices that are currently being distributed under emergency use authorizations (EUAs) or that fall under specific policies issued to support the response to the COVID-19 pandemic. The agency states that they recognize that it will take time for manufacturers and others to adjust to “normal operations” as policies adopted during the pandemic come to an end. However, they are recommending that organizations move quickly to plan their regulatory strategy and engage with the agency where necessary.
The two guidance documents are:
Advance notices will be published in the Federal Register for each EUA declaration 180 days prior to the termination of the EUA.
For devices that fall within enforcement policies issued during the COVID-19 public health emergency (PHE), a 180-day transition period is also available and will begin following the expiration of the section 319 PHE declaration. Manufacturers should refer to the following “list 1” COVID-19 public health emergency enforcement policies for more detail:
The FDA’s stated intent with this guidance is to, among other things, “help avoid disruption in device supply and help facilitate compliance with applicable FD&C act requirements after the termination of the relevant EUA declaration…”
The following guiding principles are taken directly from the guidance documents listed at the beginning of this article, and they are the same in both documents.
Manufacturers who intend to seek market authorization for devices currently under COVID-19-related EUAs should begin working on their market submission and transition implementation plan as soon as possible. The CDRH is encouraging organizations that want to continue marketing their device, and need a marketing submission, to take advantage of the full transition period, including submitting a pre-submission if needed. The pre-submission process allows for early interactions with the CDRH.