FDA Outlines Post-Pandemic Plan for Medical Devices Now Marketed Under Special COVID Rules

The U.S. Food and Drug Administration (FDA) recently announced its plan to provide medical device manufacturers 180 days to secure marketing authorization or clearance for medical devices that have been marketed under special rules during the COVID-19 pandemic, once such announcement is published either through final guidance or in the Federal Register. This will likely apply to personal protective equipment (PPE) – masks, face shields, gowns and surgical gloves – as well as diagnostic tests, ventilators, disinfectants and respirators, as many of these products were marketed under FDA enforcement policies or under an Emergency Use Authorization (EUA). Manufacturers will be required to comply with relevant FDA medical device regulations as part of the transition.

Specifically, on Dec. 22, 2021, the FDA released two draft guidances regarding transitioning medical devices brought to market during the public health emergency (PHE) caused by COVID-19 once the PHE is over. During the PHE, FDA has used two vehicles – enforcement policies and EUAs – to allow certain otherwise unapproved or unauthorized devices to be lawfully marketed provided that manufacturers complied with requisite rules. The newly released guidances provide detailed instructions for manufacturers of such products to ensure that the products will be lawfully marketed once the PHE is declared over.

FDA's draft guidance governing medical devices that fall within enforcement guidance policies issued during the PHE (Transition Plan for Medical Devices That Fall Within Enforcement Policies Issued During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency) explains manufacturer requirements for these products once the enforcement policies are no longer in effect. The draft guidance on devices brought to market under an EUA (Transition Plan for Medical Devices Issued Emergency Use Authorizations (EUAs) During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency) provides information about the steps manufacturers must take to ensure that these products are being lawfully marketed once the EUA is no longer in effect after the PHE.

Manufacturers should review these draft guidances and consider taking steps immediately to position their products for an environment in which the only way to market a medical device is through the traditional pathways such as the 510(k) process. Manufacturers should begin preparing their applications for marketing as soon as possible. Although the guidances allow for a transition period, they make clear that FDA will require manufacturers to submit their applications prior to the last phase of the transition process.

Interested stakeholders are invited to submit comments on the draft guidances to the FDA, which by law is required to review and consider all comments. Comments are due on March 23, 2022. The FDA has scheduled a webinar on Feb. 22, 2022, for industry stakeholders and others interested in learning more about the draft guidances. Whether or not a medical device manufacturer comments on the draft guidances, manufacturers and distributors should pay close attention to the policies contained within them, as the consequence for non-compliance could be severe and include product recall.

A summary of key details from the draft guidances follow. More information can be provided upon request.

Medical Devices That Fall Within Enforcement Policies Issued During the PHE

In response to the shortage of many medical devices critical to the diagnosis, prevention and treatment of COVID-19, FDA issued a series of enforcement policies that allowed for the marketing of devices otherwise not cleared or approved (provided that manufacturers complied with certain requirements).

In its December draft guidance, FDA noted that many of these policies would no longer be in effect once the PHE is over. Consequently, manufacturers of such medical devices will need to take steps to ensure that their products are in regulatory compliance or risk facing FDA enforcement action.

In the guidance, FDA provides a tentative list of the enforcement policies that will no longer be in effect. Policies impacting the following devices are listed as being impacted:

• face masks, barrier face coverings, surgical masks and respirators
• gowns and gloves
• sterilizers, disinfectant devices and air purifiers
• ventilators and accessories and other respiratory devices

Phased Transition Plan

FDA proposes that these requirements will become fully enforced 180 days after issuance of a final guidance, at which time the COVID-19 enforcement policies will be withdrawn. FDA notes, however, that if the final guidance is issued before the expiration of the PHE declaration, the implementation date would be the date that the PHE declaration expires – and companies would have 180 days from that date.

Alternatively, if the final guidance is not issued prior to the expiration of the PHE, FDA says it will not immediately withdraw the enforcement policies, but rather would announce the 1) implementation date in that guidance, which would be at least 45 days after the finalization of the guidance; and 2) the withdrawal date of the identified enforcement policy guidances, which would be at least 180 days after the implementation date.

FDA envisions a transition plan with three phases that gradually increase regulatory requirements such that, by Phase 3, a manufacturer can (and must) submit a marketing application.

• 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).
• Phase 2: Begins 90 days after the implementation date. Before the start of Phase 2 and 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).
• Phase 3: Begins 180 days after the implementation date. At the start of Phase 3, FDA intends to withdraw the identified enforcement policy guidances, 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 authorization.

Prior to the start of Phase 3, 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 enforcement policies are no longer in effect. 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.

Importantly, FDA says it does not intend to object to the continued distribution of devices within the scope of this guidance where a marketing submission has been submitted and accepted by FDA before the start of Phase 3 and where FDA has not taken a final action on the marketing submission.

Once a product receives marketing clearance or approval, FDA expects manufacturers to comply with all applicable statutory and regulatory requirements for their devices.

In the draft guidance, FDA urges manufacturers that have questions to use the Q-Submission Program, including Pre-Submissions, to develop plans to address their specific scenarios if they are not discussed in the guidance.

The draft guidance also contains instructions for manufacturers for situations where they intend to continue distributing their devices as described in an enforcement policy after the relevant guidance has been withdrawn. For example, FDA said it does not generally intend to object to the disposition of "single use, non-life-supporting/non-life-sustaining devices (e.g., face masks)" that were distributed before the withdrawal of the relevant guidances if they remain distributed and are consumed by the end user.

Medical Devices Issued EUAs During the COVID-19 PHE

Under the Federal Food Drug, and Cosmetic Act (FDCA), after the U.S. Department of Health and Human Services (HHS) Secretary has made a declaration of emergency or threat justifying authorization of emergency use (an "EUA declaration"), FDA can authorize the emergency use of an unapproved product or an unapproved use of an approved product for certain emergency circumstances. FDA has used this authority many times since early 2020 as part of its response to the COVID-19 outbreak.¹

An EUA issued under this provision will remain in effect for the duration of the relevant EUA declaration. When an EUA declaration is terminated, all EUAs issued under that declaration also terminate.

According to FDA, the advance notice of termination of each EUA will be published in the Federal Register 180 days before the day on which the EUA declaration is terminated.

As with other devices noted above, FDA suggests that manufacturers use the Q-Submission Program, including Pre-Submissions, to dialogue with the agency and develop plans to address specific situations not addressed by the guidance.

For manufacturers that intend to continue distributing their devices after the EUA termination date, FDA recommends that manufacturers submit their marketing submissions to FDA with sufficient time for the submission to be accepted by FDA before the EUA termination date.

After the EUA termination date, when an accepted marketing submission is under consideration by FDA and once the device receives marketing authorization from the agency, FDA expects that manufacturers will comply with all applicable regulatory requirements for the device/manufacturer, including but not limited to the applicable marketing submission requirements, Quality System Regulations, adverse event reporting requirements, registration and listing, and Unique Device Identification.

Before the EUA termination date, FDA expects manufacturers who intend to distribute their devices after the EUA termination date to have completed any steps necessary to transition into compliance with all FDCA requirements applicable to their devices once their EUAs are no longer effective.

FDA expects that some marketing submissions will include changes or updates to the device. FDA recommends that manufacturers provide a "transition implementation plan" along with its submission that includes the manufacturers' plans for devices already distributed in the case of a positive decision or in the case of a negative decision.

FDA does not intend to object to the continued distribution of devices after the EUA termination date where:

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

When a manufacturer does not intend to continue to distribute its device beyond the EUA termination date, FDA generally does not intend to object to the disposition of already distributed devices (i.e., FDA does not intend to request market removal) where:

• single use, non-life-supporting/non-life-sustaining devices (e.g., face masks) that were distributed before the EUA termination date remain distributed and are consumed by the end user
• reusable, non-life-supporting/non-life-sustaining devices (e.g., remote patient monitoring devices) that were distributed before the EUA termination date remain distributed and are used by the end user

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

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

For questions regarding the FDA guidance that are specific to your organization or for assistance in drafting and submitting comments on the guidance, please contact the authors.

Notes

¹ A list of all authorized COVID-19 device EUAs is available on the FDA website.

Information contained in this alert is for the general education and knowledge of our readers. It is not designed to be, and should not be used as, the sole source of information when analyzing and resolving a legal problem, and it should not be substituted for legal advice, which relies on a specific factual analysis. Moreover, the laws of each jurisdiction are different and are constantly changing. This information is not intended to create, and receipt of it does not constitute, an attorney-client relationship. If you have specific questions regarding a particular fact situation, we urge you to consult the authors of this publication, your Holland & Knight representative or other competent legal counsel.