FDA Issues Draft Guidance in Prep for End of Public Health Emergency

We recently published a post describing the FDA’s recent actions to roll back the enforcement policy implemented in response to the COVID-19 pandemic. On December 22, 2021, the FDA announced a pandemic (enforcement policy device) for devices approved under the Emergency Use Authorization (EUA) process (EUA devices) and after the COVID-19 (PHE) public health emergency is over. ) Will occur. These Guidance Documents, Medical Device Transition Plans (EUA) (COVID-19) issued during Coronavirus Disease 2019 Public Health Emergency and Transition Plans (COVID-19) applicable to the enforcement policy issued during Coronavirus Disease 2019 19)) Public health emergencies (transition planning guidance) are being marketed as new devices or legally to assist in the diagnosis, cure, treatment, or alleviation of COVID-19 symptoms, especially for pandemics. It is very important for the manufacturer who developed and manufactured the device. Both the EUA and FDA enforcement policies are temporary and are designed to end when the PHE ends. At that point, devices that have received the EUA, or that have been developed, manufactured, labeled, and distributed in accordance with the FDA’s enforcement policy, will suddenly lose marketing approval. Or at the discretion of execution. Migration planning guidance helps device manufacturers continue to commercialize the devices they need for long-term compliance with COVID-19 in preparation for the termination of PHE.

The migration planning guidance establishes a similar migration framework for EUA and enforcement policy devices, each informing the manufacturer of the start of the migration, after which the manufacturer prepares and submits an application for appropriate marketing approval. A specific period of time that needs to follow. As expected, both migration planning guidance will discontinue distribution of EUA or enforcement policy devices if the manufacturer does not submit a marketing submission and the FDA does not approve by the end of the specified transition period. It states that it is necessary. Of course, manufacturers must also comply with all applicable device regulations at the end of the transition period, including registration and listings, quality system requirements, unique device identifiers (UDIs), and other labeling requirements. .. EUA and enforcement policy devices that are Class I or exempt from premarket notification requirements do not have to comply with the marketing submission requirements of the migration planning guidance.

Importantly, the COVID-19 test manufacturer must follow the EUA migration planning guidance, as the enforcement policy transition planning guidance explicitly excludes the COVID-19 in vitro diagnostic test.

In both guidance, the FDA states that government agencies have announced the start of a transition period for EUA and enforcement policy devices in the Federal Register, which will end in 180 days. The migration periods for both types of devices are similar in terms of duration, but there are some differences. In particular, it is not clear whether the FDA will start the transition period at the same time. In addition, the EUA Transition Planning Guidance does not provide a specific structure for the transition period, but the Enforcement Policy Transition Planning Guidance divides the transition period into three phases.

• Phase 1 begins on the day of the FDA’s announcement. Authorities expect manufacturers to begin compliance if they have not yet complied with the Adverse Event Reporting Requirements (21 CFR Part 807).

• Phase 2 begins 90 days after the start date. Before Phase 2 begins, government agencies expect manufacturers to begin complying with the amendment and deletion reporting requirements (21 CFR Part 806). If the manufacturer plans to distribute the enforcement policy device after the transition period, the manufacturer must register and list with the FDA before the start of Phase 2.

• Phase 3 begins 180 days after the start date. The FDA has withdrawn its enforcement policy and manufacturers are expected to comply with all applicable device regulations at the start of Phase 3.

If the FDA receives and accepts a marketing request for an enforcement policy device prior to the start of Phase 3, the manufacturer can continue marketing and distributing the device. However, if the FDA does not receive a marketing submission for the enforcement policy device prior to the start of Phase 3, or if the FDA makes a negative decision regarding the marketing submission for the device, the manufacturer will discontinue the distribution of such device. need to do it.

For EUA devices, manufacturers wishing to distribute such devices after the transition period must submit a marketing submission for the EUA device before the end of the 180-day period, which the FDA must accept. .. The FDA will terminate all EUAs at the end of the transition period, so manufacturers who choose not to distribute EUA devices after the transition period, and have not submitted marketing submissions, or have been negative about marketing submissions from the FDA. Manufacturer EUA devices that receive the decision must discontinue distribution on the end date.

FDA informs FDA whether the manufacturer of a particular reusable life support or life support EUA or enforcement policy device submits a marketing submission to support the continued distribution of such device. We recommend that you submit a “Notice of Intent”. If the manufacturer does not plan to submit a marketing submission, the notice will provide a plan to discontinue distribution, a plan to restore the EUA or enforcement policy device to a legally sold version, and an updated label. The plan, and other measures to address or mitigate the potential risks associated with the change, should be documented with respect to the EUA or enforcement policy. In addition, the FDA requires manufacturers to include a “migration implementation plan” as part of each marketing submission for EUA or enforcement policy devices. The migration implementation plan should provide the following information:

• Estimated number of distributed devices.

• Benefit risk-based planning for the disposal of distributed devices if the FDA makes a negative decision regarding marketing submissions.When

• A plan to deal with distributed devices if the FDA makes a positive decision regarding marketing submissions.

In particular, if any changes or modifications to the EUA or enforcement policy device already distributed are required to comply with the specifications set forth in the marketing submission, the manufacturer will modify or modify such devices from the market. We need to discuss the removal plan. In addition, the FDA may require manufacturers to initiate recalls of devices that have already been distributed, if necessary.

Finally, for EUA or enforcement policy devices that are deprecated after the end of the implementation period, the FDA requires that devices distributed prior to the end date be removed from the market if any of the following categories apply: There are no plans.

• Disposable, non-life-sustaining / non-life-sustaining devices consumed by end users.

• Reusable, non-life-sustaining / non-life-sustaining device that has been restored to a legally sold version or has an updated label that accurately describes the function and regulatory status of the product. Published (that is, the device has not been approved or approved by the FDA).

• A physical copy and publication of an updated label that has been restored to a legally sold version or that accurately describes the product’s functionality and regulatory status (that is, the device has been approved or approved by the FDA). Not received), reusable life-sustaining / life-sustaining devices).

• An invitro diagnostic device used within 2 years of the EUA’s end date or expiration date.

While the 180 days of the transition period prior to the end of the COVID-19 EUA and FDA Enforcement Policy seems to be a considerable amount of time, manufacturers are likely to include significant marketing, including new information requested by the FDA in the transition planning guidance. You need to prepare your submission. In some cases, we will implement appropriate systems and controls to ensure compliance with applicable device regulations by the end of such periods. On December 21, 2021, the EUA and enforcement policy devices are not rolling-based, as CDRH issued more than 1,900 EUA to devices during a pandemic and continues to receive more than 100 EUA requests per month. , Will be submitted towards the end of the transition period. The release of migration planning guidance marks the beginning of preparations for migration by the FDA, so EUA and enforcement policy device manufacturers will consider whether to continue distributing such devices after the migration period. By familiarity you should start your own preparations as well, and start making plans to comply with traditional device regulations.

The FDA is currently accepting public comments on transition planning guidance and is planning a webinar for stakeholders regarding the plan for February 22, 2022. Those interested in commenting on one or both of the draft guidance should submit their comments to Docket FDA-2021-D. Organize -1118 for enforcement policy transition plan guidance and FDA-2021-D-1149 for EUA transition plan guidance.