COVID-19 EUA and Enforcement Policy Transition Plans

In December of 2021, the FDA issued two draft guidance documents for transition plans for medical devices that were issued Emergency Use Authorizations (EUAs) and for devices that fall within enforcement policies issued during the COVID-19 Public Health Emergency (PHE) respectively. This was the first indication that the FDA was beginning to look forward towards the end of the COVID-19 Public Health Emergency era. Recent regulatory conversations have shown that the FDA continues to look forward to beginning the transition as they start urging companies to look towards 510(k)’s over EUAs. While the FDA will continue to accept EUAs at this time, it is important for companies to begin preparing for their EUAs to expire. In this blog, we aim to highlight the importance of thinking ahead and how RookQS can help you take this on. 

Notice of termination of each EUA will be published by the Federal Register 180 days before the day when the EUA will be terminated, known as the “EUA termination date”. Once terminated, devices will no longer be authorized for use. The FDA does not wish to induce strain in the supply chain, so they are recommending that companies marketing devices that are currently authorized under EUAs begin planning their post-EUA strategy now.

On the other hand, the devices which fall within the COVID-19 enforcement policies will transition in three phases. The FDA is still considering the implementation date of the Phase 1 of this transition and they have put forward two possible scenarios. In the event when the draft guidance document is finalized prior to the expiration of the COVID-19 section 319 PHE declaration, the implementation date would be the date the COVID-19 section 319 PHE declaration expires. In another scenario, if the COVID-19 section 319 PHE expires prior to issuance of final guidance, The FDA intends to announce the implementation date to be at least 45 days after the final guidance was issued. In both cases, the FDA does not intend to withdraw the enforcement policies until 180 days after the implementation date. The final phase of this transition (i.e. Phase 3) will begin after the guidance documents citing enforcement policies are withdrawn.

These guidance were developed by the FDA with the following principles in mind: 

• Intent to help facilitate continued patient, consumer, and healthcare provider access
• Orderly and transparent transition for devices
• Risk-based approach with consideration of differences in the intended use and regulatory history of devices

Companies providing certain reusable life-supporting devices should provide “notifications of intent” letting the FDA know whether or not they plan to market the product after the EUA termination date.

Manufacturers of authorized devices that intent to continue distributing their devices after the EUA termination date must submit a marketing submission to the FDA for review and approval. The marketing submission should be submitted as soon as possible after the notification of termination in order to give the FDA sufficient time for review. If the marketing submission is under review after the termination date, the FDA expects the manufacturers to comply with any applicable regulations, as well as the content of the marketing submission. This review process may require the manufacturer to engage with the agency.

For the device which fall under the COVID-19 enforcement policy, FDA expects and recommends that,

• During Phase 1 of the transition, manufacturers should follow 21 CFR Part 803
• Before the start of the Phase 2 , manufacturers should follow 21 CFR 806. If the manufacturers are planning to continue to distribute their devices, then they should also follow 21 CFR Part 807 Subparts B-D.
• Before the start of Phase 3 of the transition, the FDA expects the manufacturers to submit any marketing submission for a device within the scope of the guidance to be submitted and accepted if the manufacturer is planning to continue to distribute the devices. The FDA advises the manufacturer to complete such submission well in advance of the start of Phase 3 as otherwise it may get delayed due to large influx of new submissions. Once Phase 3 begins, the FDA expects that the manufacturer will start to comply with all statutory and regulatory requirements applicable to their devices.

In both the guidance documents, the FDA has recommended the manufacturers to include a “transition implementation plan” along with their marketing submission. A “transition implementation plan” should prepare the company for a positive response to the marketing submission or a negative one, including a benefit-risk based plan for disposition of already distributed products if the company were to receive a negative decision. If the plan is to leave distributed product on the market in the event of a negative decision, the plan should include: 

• 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 version previously approved by the FDA, including appropriate labeling
• A description of the maintenance plan

Plans for already distributed product in the event of a positive decision include: 

• Process for notifying patients, consumers, healthcare facilities, healthcare providers, and distributors of the device’s regulatory status
• Process and timeline for providing users of distributed product with the updated labeling or components that reflect any changes made to the cleared or approved device.

During submission reviews, the FDA may engage with the manufacturer to discuss the appropriate disposition of product that has been distributed to users including corrections, removals, or even recalls. 

FDA recognizes that manufacturers are now struggling to adapt and adjust their operation during the COVID-19 PHE. Thus, the FDA does not intend to block the distribution of devices within the scope of the guidance document in the cases of: 

• The manufacturer has submitted a marketing submission to the FDA and had it accepted by the FDA before the EUA termination date. For the devices which fall under the enforcement policy, the marketing submission should be accepted before the start of Phase 3. 
• The FDA has not taken a final action on the marketing submission

If  a manufacturer decides not to continue to distribute their device after the withdrawal guidance citing enforcement policies or after EUA termination date, then it is advisable to consult the FDA’s guidance document for further action items.

There are two situations in which a manufacturer would be expected to discontinue distribution of a device. The first being the EUA termination date or Phase 3 (for devices which fall within COVID-19 enforcement policies) is reached and the manufacturer did not submit a marketing package for review. The second is a negative decision from the FDA after review of a marketing submission submitted by the manufacturer or manufacturer withdraws its submission or fails to provide a complete response to an FDA request for additional information within the stipulated time-frame.

Here at RookQS, we know first-hand how much hard work companies put into obtaining an EUA or meeting the regulatory requirements, and we’re here to help you continue to market your device following its EUA termination or withdrawal of the guidance documents. Contact us for personalized guidance on a transition plan and 510(k) submission support for your device. 

Contact us for a consultation or to request our FREE interactive tool to assess how your company can prepare for the future—and how Rook can help.