In two draft companion guidance documents, the US Food and Drug Administration (FDA) establishes a proposed framework for transitioning medical devices currently marketed under emergency use authorization (EUA) or enforcement policy guidance to permanent marketing authorization. The draft FDA guidance documents provide manufacturers a 180-day transition period to submit a marketing application and stress that they should submit permanent marketing authorizations prior to finalization of the guidance documents.
Late last month, the FDA published two eagerly anticipated draft guidance documents establishing a proposed framework for transitioning certain COVID-19-related medical devices to permanent marketing authorization:
Key takeaways from the two draft guidance documents include the following:
Comments on both draft guidance documents are due by March 23, 2022. Additionally, the FDA will host a public webinar on February 22, 2022, to discuss the draft guidance documents.
The EUA Draft Transition Guidance covers devices authorized under an EUA. In this draft guidance, FDA states its intent to publish in the Federal Register advance notice of an EUA termination 180 days prior to the date the termination is effective (EUA Termination Date).
For manufacturers that intend to continue marketing after the EUA Termination Date:
The FDA will permit manufacturers to continue marketing their EUA devices after the EUA Termination Date while their permanent marketing applications are pending.
For manufacturers that do not intend to continue marketing after the EUA Termination Date, the EUA Draft Transition Guidance provides specifics on the disposition of already distributed devices based on whether the devices are single use versus reusable, non-life-supporting/non-life-sustaining versus life-supporting/life-sustaining, or in vitro diagnostic devices.
FDA asks that manufacturers of certain EUA-authorized, reusable, life-supporting/life-sustaining devices (e.g., oxygen concentrators and ventilators) submit a “Notification of Intent” indicating whether they intend to submit a permanent marketing application. The agency intends to use this information to help ensure that it has appropriate staffing in preparation for the potential onslaught of marketing applications it may receive.
The Enforcement Policy Draft Transition Guidance covers devices marketed under one of the 17 enforcement policies issued during the COVID-19 pandemic. Similar to the EUA Draft Transition Guidance, the Enforcement Policy Draft Transition Guidance proposes a 180-day transition period for manufacturers of devices covered by a COVID-19 enforcement policy, which would start from the “implementation date.” The specific implementation date will depend on when the FDA finalizes the draft guidance, as indicated below:
Timing of Guidance Finalization
Before the COVID-19 PHE declaration expires
After the COVID-19 PHE declaration expires
The date the PHE declaration expires
At least 45 days after the date the guidance is finalized
During the 180-day period starting on the implementation date, the FDA expects manufacturers to comply with a host of regulatory requirements in a three-phase transition plan:
For manufacturers that intend to continue marketing their devices after the start of Phase 3:
Similar to the EUA Draft Transition Guidance, the Enforcement Policy Draft Transition Guidance provides:
Morgan Lewis guides and provides strategic counseling to medical device developers in order to bring novel technologies to market utilizing the least burdensome FDA regulatory approach. Morgan Lewis prepares marketing applications (e.g., EUA, 510(k), De Novo) and interacts with the FDA to help ensure timely review and authorization of applications.
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