FDA Proposes Framework for Transitioning COVID-Related Medical Devices from EUA/Enforcement Discretion to Permanent Marketing Authorization

Morgan Lewis
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Morgan Lewis

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Late last month, the FDA published two eagerly anticipated draft guidance documents establishing a proposed framework for transitioning certain COVID-19-related medical devices to permanent marketing authorization:

Key takeaways from the two draft guidance documents include the following:

  • Manufacturers will have 180 days to submit a marketing application once the FDA triggers the relevant transition period. After the 180 days, a manufacturer may continue to market its device while the application is pending, provided that the FDA accepted the application for substantive review prior to the end of the 180-day period.
  • The transition period will likely begin once the COVID-19 public health emergency (PHE) declaration expires. Given the current state of the pandemic with the Omicron variant, expiration of the PHE is not likely imminent (and potentially not in 2022).
  • There is no abbreviated marketing application process for EUA holders, i.e., they must submit a full marketing application to the FDA for their devices.
  • Manufacturers will be expected to comply with all regulatory requirements at the end of the 180-day period, even if their marketing applications are still pending.
  • Manufacturers should consider submitting their marketing applications prior to finalization of the guidance documents/initiation of the transition periods.

Comments on both draft guidance documents are due by March 23, 2022. Additionally, the FDA will host a public webinar on February 22, 2022, to discuss the draft guidance documents.

FRAMEWORK FOR MEDICAL DEVICES MARKETED PURSUANT TO AN EUA

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 In this draft guidance, FDA states its intent to publish in the Federal Register advance notice of an EUA termination 180 days prior to the date the termination is effective (EUA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 manufacturer must: (1) submit a new, permanent marketing application (e.g., a 510(k) premarket notification, de novo request, or premarket approval application); and (2) the application must be accepted by the FDA for substantive review before the EUA Termination Date. If the application is not accepted prior to the EUA Termination Date, the manufacturer must cease marketing the device.
  • The draft guidance does not indicate any leniency in the content of the permanent marketing application; manufacturers must submit a complete marketing application despite having already submitted information to the FDA on their devices via EUAs.
  • For situations where changes have been made to a device under EUA, the FDA notes that there is a risk the agency may not permanently authorize such changes. For such cases, the FDA recommends that manufacturers include in their marketing application a “transition implementation plan” for dealing with already distributed devices in the event of either a positive or negative decision by the FDA on the marketing application.

The FDA will permit manufacturers to continue marketing their EUA devices after the EUA Termination Date while their permanent marketing applications are pending.

  • However, the labeling for the device must be updated to state that the product was authorized under an EUA issued during the COVID-19 PHE and remains under FDA review for clearance or approval.
  • In addition, the device must comply with all applicable FDA regulatory requirements, including the Quality System Regulation (QSR), Medical Device Reporting (MDR), establishment registration and device listing, and Unique Device Identification (UDI) requirements.
  • Hence, manufacturers will need to comply with a host of regulatory requirements that were not previously required for their EUA devices.

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.

FRAMEWORK FOR MEDICAL DEVICES MARKETED PURSUANT TO AN ENFORCEMENT POLICY

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

Implementation Date

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:

  • Phase 1 begins on the implementation date. Manufacturers must ensure they follow the MDR requirements (21 C.F.R. Part 803).
  • Phase 2 begins 90 days after the implementation date. Manufacturers must ensure they follow the corrections and removals reporting requirements (21 C.F.R. Part 806), as well as the registration and listing requirements (21 C.F.R. Part 807).
  • Phase 3 begins 180 days after the implementation date. The FDA will withdraw the enforcement policies and manufacturers will be expected to comply with all regulatory requirements applicable to their devices, including QSR, MDR, registration/listing, labeling, and UDI requirements.

For manufacturers that intend to continue marketing their devices after the start of Phase 3:

  • The manufacturer must: (1) submit a new marketing application (e.g., a 510(k), de novo, or PMA); and (2) the application must be accepted by the FDA for substantive review prior to the start of Phase 3. If the application is not accepted prior to that time, the manufacturer must cease marketing. If accepted, the manufacturer may continue to market while the application is pending.
  • For situations where changes have been made to a device distributed under an enforcement policy, the FDA notes that there is a risk that it may not permanently authorize such changes. For such cases, the FDA recommends that manufacturers include in their marketing application a “transition implementation plan” for dealing with already distributed devices in the event of either a positive or negative decision by the FDA on the marketing application.

Similar to the EUA Draft Transition Guidance, the Enforcement Policy Draft Transition Guidance provides:

  • Specific guidance for manufacturers that do not intend to distribute their devices after the withdrawal of the enforcement policy guidance documents.
  • An FDA request that manufacturers of certain reusable, life-supporting/life-sustaining devices covered by an enforcement policy (e.g., anesthesia devices, ventilators, and humidifiers) submit a “Notification of Intent” indicating whether they intend to submit a marketing application.

[View source.]

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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