On December 22, 2021, the U.S. Food and Drug Administration (FDA) issued two draft guidance documents for the transition plans for medical devices commercialized pursuant to either Emergency Use Authorization (EUA) or the FDA’s Enforcement Policies during the Coronavirus Disease 2019 (COVID-19) public health emergency (COVID-19 PHE). The draft guidance for EUAs can be located here, and the draft guidance for devices commercialized under the FDA’s COVID-19 Enforcement Policies can be located here.

This alert provides an overview of the draft guidance(s).

Overview

The FDA acknowledged early during the COVID-19 PHE the importance of maintaining the availability of certain devices during the pandemic, also taking into consideration the impact of supply chain limitations. In response, the FDA issued various guidance documents that describe enforcement policies for certain devices that are intended to support the emergency response to the COVID-19 PHE.

The FDA recognizes that it will take time for device manufacturers, healthcare facilities, healthcare providers, patients, consumers, and the FDA to adjust from the policies adopted and operations implemented during the declared COVID-19 public health emergency to someday resuming normal regulatory operations.

To provide a clear policy, the FDA has issued two draft guidances to describe the FDA’s general recommendations for a phased transition process with respect to devices that fall within the enforcement policies issued during the COVID-19 PHE, including recommendations regarding submitting a marketing application (e.g., 510(k), De Novo, or PMA), as applicable, and taking other actions with respect to these devices.

For more information, the FDA will host a webinar on the guidance on February 22, 2022. The draft guidance(s), which are currently nonbinding, will be open to public comments until March 23, 2022.

Transition Plan for Devices Authorized Under an EUA

The FDA states that advance notice of termination for each EUA will be published in the Federal Register 180 days before the day it is terminated. From the time between advance notice and termination date, manufacturers must continue to comply with the obligations under the respective EUA. After the termination date, the manufacturer must follow the proper channels laid out in the guidance or discontinue manufacturing.

The FDA recommends that manufacturers of specific reusable life-supporting or life-sustaining devices issued under an EUA (listed in the table below) inform the FDA as soon as possible after the guidance has been finalized regarding whether or not they intend to submit a marketing application to continue distributing their product after the EUA termination date.

Specifically, the EUA requests that manufacturers of devices in the table above submit a cover letter titled: “Attention: Notification of Intent” and include the following information to the CDRH Document Control Center as soon as possible:

1. General information, including contact information, name and place of business, and email address;
2. EUA request number;
3. Submission number(s) for related premarket submissions;
4. A list of all model numbers or other device identifying information;
5. Whether the manufacturer intends to submit a marketing submission; and  
6. If not planning to submit a marketing submission, the manufacturer should discuss, as applicable, its plans to discontinue distribution of the device, to restore the device to a previously FDA-cleared or -approved version, to provide a physical copy or electronic updated labeling, and any other efforts to address or mitigate potential risks of devices that remain distributed after the EUA termination date.

The FDA also recommends that manufacturers include a “transition implementation plan” along with their marketing submission. The FDA recommends including the following information:

• Estimated number of devices under an EUA currently that are in U.S. distribution;
• An explanation of the manufacturer’s benefit-risk based plan for disposition of already distributed product in the event of a negative decision on the marketing submission. If the manufacturer is proposing to leave already distributed product in place, the plan should address the rationale for doing so and considerations such as the following, where relevant:
  • process for notifying patients, consumers, healthcare facilities, healthcare providers, and distributors of the device’s regulatory status;
  • process and timeline for restoring distributed devices to the previously FDA cleared or approved version, providing publicly available labeling that accurately describes the product features and regulatory status, or providing both publicly available and a physical copy of updated labeling for reusable life-supporting/life sustaining devices to describe their regulatory status; and
  • description of the maintenance plan for distributed devices.
• An explanation of the manufacturer’s plans for addressing already-distributed product in the event of a positive decision on the marketing submission, including considerations such as the following, where relevant:
  • process for notifying patients, consumers, healthcare facilities, healthcare providers, and distributors of the device’s regulatory status; and
  • process and timeline for providing to users of previously distributed devices, updated labeling, or components that reflect any changes made to the cleared or approved device.

The FDA recognizes it may take time for manufacturers to adjust operations back to normal operations. The FDA does not intend to object to the continued distribution of devices within the scope of the guidance after the EUA termination date where:

• the manufacturer has submitted a marketing application to the FDA and had it accepted by the FDA before the EUA termination date; and
• the FDA has not taken a final action on the marketing application.

The FDA expects manufacturers to discontinue distribution of a device within the scope of this guidance if:

• on the EUA termination date, if the manufacturer has not submitted a required marketing application for its device and had it accepted by the FDA before the EUA termination date; or
• on the date the manufacturer receives a negative decision on its marketing application as the FDA’s final action, or on the date the manufacturer withdraws its application or fails to provide a complete response to an FDA request for additional information within the time identified in the FDA’s letter.

Transition Plan for Devices Commercialized Under an Enforcement Policy Issued During the COVID-19 PHE

The FDA’s guidance on transitioning devices that were commercialized under an enforcement policy issued during the COVID-19 PHE applies to devices issued under the Enforcement Policies listed below. The FDA reserves the right to add or remove documents from the below list as appropriate. As such, the below draft list may not reflect the finalized list that will be published in the final guidance.

• Remote Digital Pathology Devices During the COVID-19 Public Health Emergency
• Imaging Systems During the COVID-19 Public Health Emergency
• Non-Invasive Fetal and Maternal Monitoring Devices Used to Support Patient Monitoring During the COVID-19 Public Health Emergency
• Telethermographic Systems During the COVID-19 Public Health Emergency
• Digital Health Devices for Treating Psychiatric Disorders During the COVID-19 Public Health Emergency
• Extracorporeal Membrane Oxygenation and Cardiopulmonary Bypass Devices During the COVID-19 Public Health Emergency
• Remote Ophthalmic Assessment and Monitoring Devices During the COVID-19 Public Health Emergency
• Infusion Pumps and Accessories During the COVID-19 Public Health Emergency
• Clinical Electronic Thermometers During the COVID-19 Public Health Emergency
• Face Masks, Barrier Face Coverings, Face Shields, Surgical Masks, and Respirators During the COVID-19 Public Health Emergency (Revised)
• Gowns, Other Apparel, and Gloves During the COVID-19 Public Health Emergency
• Sterilizers, Disinfectant Devices, and Air Purifiers During the COVID-19 Public Health Emergency
• Ventilators and Accessories and Other Respiratory Devices During the COVID-19 Public Health Emergency
• Non-Invasive Remote Monitoring Devices Used to Support Patient Monitoring During the COVID-19 Public Health Emergency (Revised)
• Modifications to FDA Cleared Molecular Influenza and RSV Tests During the COVID-19 Public Health Emergency
• Quality Standards of the Mammography Quality Standards Act During the COVID-19 Public Health Emergency
• Coagulation Systems for Measurement of Viscoelastic Properties During the COVID-19 Public Health Emergency (Revised)

The FDA is proposing a transition period which will begin on a currently non-specified implementation date, as part of a three-phase rollout. The implementation date will be at least 45 days upon finalization of the draft guidance and then withdraw the Enforcement Policies specified above at least 180 days after the implementation date.

• Phase 1: Begins on the implementation date. If not already doing so, manufacturers should follow 21 CFR Part 803 (i.e., adverse event reporting requirements) in order to prepare for Phase 3.
• Phase 2: Begins 90 days after the implementation date. Before the start of Phase 2 and in order to prepare for Phase 3, if not already doing so, manufacturers should follow 21 CFR Part 806 (i.e., reports of corrections and removals requirements), and if planning to continue to distribute their devices after the transition period should also follow 21 CFR Part 807 Subparts B-D (i.e., registration and listing requirements).

Before the start of Phase 2, The FDA recommends that manufacturers of specific reusable life-supporting or life-sustaining devices (listed in the table below) inform the FDA regarding whether or not they intend to submit a marketing submission to continue distributing their product.

Manufacturers of devices in the table above submit a cover letter titled: “Attention: Notification of Intent” and include the following information to the CDRH Document Control Center as soon as possible:

1. General information, including contact information, name and place of business, and email address;
2. The title of the relevant enforcement policy guidance;
3. Submission number(s) for related premarket submissions;
4. A list of all model numbers or other device identifying information;
5. Whether the manufacturer intends to submit a marketing submission; and  
6. If not planning to submit a marketing submission, the manufacturer should discuss, as applicable, its plans to discontinue distribution of the device, to restore the device to a previously FDA-cleared or -approved version, to provide a physical copy or electronic updated labeling, and any other efforts to address or mitigate potential risks of devices that remain distributed after the transition period has ended and the guidances in the list above have been withdrawn.

• Phase 3: Begins 180 days after the implementation date. At the start of Phase 3, the FDA intends to withdraw the Enforcement Policies listed above, and manufacturers will be expected to comply with all statutory and regulatory requirements applicable to their devices (e.g., 21 CFR Part 820, 21 CFR Part 801 Subpart B, and 21 CFR Part 830), except as discussed below regarding premarket applications for FDA clearance or approval. Prior to the start of Phase 3, the FDA expects any marketing submission for a device within the scope of this guidance to be submitted and accepted if the manufacturer intends to continue distribution of the device after the guidances listed above are withdrawn. Where possible, the FDA strongly encourages manufacturers to work to complete such submissions well in advance of the start of Phase 3 to avoid potential delays created by a large influx of new submissions and to best serve the public health. The FDA does not intend to object to continued distribution of devices within the scope of this guidance where a marketing submission has been submitted and accepted by the FDA before the start of Phase 3 and FDA has not taken a final action on the marketing submission.

The FDA also recommends that manufacturers include a “transition implementation plan” along with their marketing submission. The FDA recommends including the following information:

• Estimated number of devices outlined in any of the guidances listed above currently that are in U.S. distribution;
• An explanation of the manufacturer’s benefit-risk based plan for disposition of already distributed product in the event of a negative decision on the marketing submission. If the manufacturer is proposing to leave already distributed product in place, the plan should address the rationale for doing so and considerations such as the following, where relevant:
  • Process for notifying patients, consumers, healthcare facilities, healthcare providers, and distributors of the device’s regulatory status;
  • Process and timeline for restoring distributed devices to the previously FDA cleared or approved version, providing publicly available labeling that accurately describes the product features and regulatory status, or providing both publicly available and a physical copy of updated labeling for reusable life-supporting/life sustaining devices to describe their regulatory status; and
  • description of the maintenance plan for distributed devices.
• An explanation of the manufacturer’s plans for addressing already-distributed product in the event of a positive decision on the marketing submission, including considerations such as the following, where relevant:
  • Process for notifying patients, consumers, healthcare facilities, healthcare providers, and distributors of the device’s regulatory status; and
  • Process and timeline for providing to users of previously distributed devices updated labeling or components that reflect any changes made to the cleared or approved device.

The FDA expects manufacturers to discontinue distribution of a device within the scope of this guidance if:

• Before the beginning of Phase 3, if the manufacturer has not submitted a required marketing application for its device and had it accepted by the FDA; or
• On the date the manufacturer receives a negative decision on its marketing application as the FDA’s final action, or on the date the manufacturer withdraws its application or fails to provide a complete response to an FDA request for additional information within the time identified in the FDA’s letter.

In anticipation of this new guidance, manufacturers should begin preparing their transition strategy, so they can be ready to submit the applicable premarket application within the specified EUA or Enforcement Policy transition timeline. Manufacturers should consider whether any data gathered while operating under the EUA or Enforcement Policy can be used to support their application.