During the COVID-19 public health emergency, the United States Food and Drug Administration (FDA) has issued hundreds of Emergency Use Authorizations (EUAs) and numerous enforcement policies to facilitate the availability of important medical devices. On December 23, 2021, FDA published two draft guidances setting forth the Agency’s proposed process for transitioning the multitude of devices brought to market under these circumstances to full compliance with FDA requirements:
- Transition Plan for Medical Devices Issued Emergency Use Authorizations (EUAs) During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency (the “EUA Transition Draft Guidance”); and
- Transition Plan for Medical Devices That Fall Within Enforcement Policies Issued During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency (the “Enforcement Policies Transition Draft Guidance”).
Below we summarize some key takeaways from FDA’s proposed transition plan for manufacturers of devices marketed under a COVID-19 EUA (“EUA Devices”) and devices marketed under one of more than 15 COVID-19 enforcement policies listed in the guidance (“Enforcement Policy Devices”):
180-Day Transition Period and Regulatory Responsibilities During the Transition Period
For EUA Devices, FDA recommends that manufacturers plan now, while the pandemic is ongoing, for their post-EUA plans and strategies, as the draft guidance states the Agency plans to issue an advance notice of termination of each EUA declaration 180 days before its termination. Upon termination of the applicable EUA declaration, manufacturers of devices falling under the applicable EUA would need to comply with all statutory and regulatory requirements associated with their devices (subject to the additional considerations discussed below). During this 180-day transition period, a manufacturer of an EUA Device must continue to comply with the terms of the specific device’s EUA, including applicable Conditions of Authorization.
For Enforcement Policy Devices, FDA similarly contemplates a 180-day transition period prior to withdrawing any COVID-19 enforcement policy beginning on an “Implementation Date,” proposed to be defined by whether or not the Enforcement Policies Transition Draft Guidance is finalized before or after the expiration of the COVID-19 public health emergency declaration. During this 180-day transition period, FDA defines “phases” for when various regulatory responsibilities should begin:
- Phase 1 begins on the Implementation Date, and FDA recommends that manufacturers of Enforcement Policy Devices follow medical device reporting (“MDR”) requirements (if not already doing so). Additionally, FDA recommends that manufacturers who plan to continue to distribute such devices begin preparing the applicable marketing submission to FDA (if not already begun).
- Phase 2 begins 90 days after the Implementation Date. FDA recommends that before the start of Phase 2, manufacturers of Enforcement Policy Devices should follow requirements for reports of corrections and removals (it not already doing so), and during Phase 2 begin to follow establishment registration and device listing requirements if they plan to continue to distribute such devices.
- In Phase 3, which begins 180 days after the Implementation Date, FDA proposes to withdraw the applicable Enforcement Policies and, after that point, manufacturers would need to comply with all statutory and regulatory requirements associated with their devices (subject to the additional considerations discussed below).
“Notifications of Intent” for Certain Reusable Life-Supporting or Life-Sustaining Devices
For certain reusable life-supporting or life-sustaining devices specifically identified in the two draft guidances, FDA recommends that manufacturers submit to FDA information regarding whether or not they intend to submit a marketing submission to continue distributing the devices as soon as possible after the EUA Transition Draft Guidance is finalized (for EUA Devices) or before the start of Phase 2 (for Enforcement Policy Devices).
Devices to be Discontinued After the EUA Termination Date or Withdrawal of the Enforcement Policies
For devices that a manufacturer does not intend to continue distributing after EUA termination or withdrawal of the applicable COVID-19 enforcement policy, FDA does not intend to request market removal of certain devices distributed prior to the applicable EUA termination or enforcement policy withdrawal that remain in distribution, subject to certain conditions:
- Single use, non-life-supporting/non-life-sustaining devices (e.g., face masks).
- Reusable, non-life-supporting/non-life-sustaining devices: Such devices should either be restored by the manufacturer to the previously FDA-cleared or approved version, or have publicly available labeling that accurately describes the product features and regulatory status.
- Reusable life-supporting/life-sustaining devices: Such devices should either be restored by the manufacturer to the previously FDA-cleared or approved version, or have publicly available labeling and physical labeling that accurately describes the product features and regulatory status.
- In vitro diagnostic devices: COVID-19 tests may remain in distribution and be used by end users until two years after the EUA termination date or until the test’s expiration date, whichever comes first.
Devices Marketed After the EUA Termination Date or Withdrawal of the Enforcement Policies
For both EUA Devices and Enforcement Policy Devices, FDA intends to exercise enforcement discretion and permit continued distribution of such devices if a marketing submission (i.e., premarket approval application (PMA), PMA supplement, premarket notification (510(k)), humanitarian device exemption (HDE), or De Novo classification request) is accepted by FDA prior to the end of the 180-day transition period. This enforcement discretion applies only to the premarket clearance or approval requirement and only while the marketing submission is pending before the Agency. FDA recommends that any marketing submission address the disposition of devices distributed prior to FDA’s final decision on the marketing submission, in the event of either a potential positive or negative FDA decision.
At the end of the 180-day transition period, FDA expects manufacturers to comply with all other applicable regulatory requirements, including MDR, reports of corrections and removals, establishment registration and device listing, and the quality system regulation (QSR). While the Agency may consider requests for an exemption or variance from QSR requirements, the draft guidances recommend that such exemption or variance be requested within 90 days of publication of the notice of termination of the EUA declaration for EUA Devices and within 90 days of the announcement of the Implementation Date for Enforcement Policy Devices.
Discontinuation of Distribution of Marketed Devices
FDA expects manufacturers to discontinue distribution of EUA Devices and Enforcement Policy Devices when:
- The manufacturer has not submitted or the manufacturer has submitted but FDA has not accepted a marketing submission for the device prior to the end of the 180-day transition period;
- The manufacturer receives a negative decision on its marketing submission; or
- The manufacturer withdraws its submission or fails to provide a complete response to an FDA request for additional information within the time allotted.
As highlighted by illustrative examples provided by FDA in both draft guidances, FDA may request a firm to initiate a recall when FDA reaches a negative decision or when the firm does not respond to an FDA request for additional information within the specified timeframe.
FDA acknowledges that these draft guidance documents may not account for all possible scenarios and, as needed, encourages manufacturers to initiate discussions through the Q-Submission Program to develop transition plans for their specific medical devices.
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FDA is inviting comments on both draft guidances through March 23, 2022. For assistance in drafting and submitting comments, or for questions related to marketing submissions for EUA Devices or Enforcement Policy Devices, or for additional guidance on FDA’s proposed transition plans, please contact a member of Goodwin’s FDA Practice.
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