New guidance

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:

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

Transition periods

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:

• Digital pathology devices
• Imaging systems
• Non-invasive fetal and maternal monitoring devices
• Telethermographic systems
• Treating psychiatric disorders ‍
• Extracorporeal membrane oxygenation and cardiopulmonary bypass devices

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…”

Guiding principles

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.

• This guidance is intended to help facilitate continued patient, consumer, and healthcare provider access to devices needed in the prevention, treatment, and diagnosis of COVID19.  
• FDA believes the policies and recommendations in this guidance will help to ensure an orderly and transparent transition for devices that fall within the scope of this guidance. FDA’s policies and recommendations in this guidance are consistent with the Agency’s statutory mission to both protect and promote the public health.
• FDA’s policies and recommendations follow, among other things, a risk-based approach with consideration of differences in the intended use and regulatory history of devices, including whether the device is life-supporting or life-sustaining, capital or reusable equipment, a single-use device, and whether another version of the device is FDA cleared or -approved.  
• As always, FDA will make case-by-case decisions regarding the enforcement of legal requirements in response to particular circumstances and questions that arise regarding a specific device or device type. This may include FDA revising or revoking an EUA,29 requesting a firm initiate a recall (see 21 CFR 7.45), or taking other actions, including an enforcement action. Moreover, FDA may revise the enforcement policies and recommendations in the guidance, as appropriate.

Do not wait to submit marketing submissions

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.

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