Biden Administration Halts Proposal to Exempt Some Class II Devices Currently Subject to Enforcement Discretion from 510(k) Requirement

In one of the last proposed notices from the US Department of Health and Human Services (HHS) under the Trump administration, HHS removed the 510(k) premarket notification requirement for seven types of gloves and proposed the same for 84 other devices ranging from gowns to ventilators. It is not clear that the Biden administration will agree and a recent Biden administration memorandum put the proposal on hold.

At the beginning of the COVID-19 pandemic, to help increase the availability of certain critical-need devices to aid in the COVID-19 relief efforts, the US Food and Drug Administration (FDA) issued a slew of policies that offered enforcement discretion from compliance with FDA laws and regulations including 510(k) premarket notification, compliance with the Quality System Regulation (21 C.F.R. Part 820), and registration/listing per 21 C.F.R. Part 807. Devices offered discretion include:

• Air Purifiers intended to kill/capture SARS-CoV-2
• Clinical electronic thermometers
• Surgical gowns
• Non-invasive remote monitoring devices (e.g., oximeters, breathing frequency monitors, cardiac monitors)

For new market entrants that relied exclusively on the enforcement policies or an Emergency Use Authorization (EUA) in order to market their devices, companies have been trying to plan their path in the marketplace once the pandemic ends and FDA pulls the enforcement policies. Specifically:

• Will FDA allow companies to operate under enforcement discretion while their 510(k) premarket notification is pending?
• Will companies need to remove products in the marketplace that were marketed under enforcement discretion?
• Will FDA offer an expedited and/or abbreviated 510(k) review process?

FDA has stated that “manufacturers may submit the appropriate premarket submission to legally market their product after the EUA declaration is terminated or the EUA is otherwise revised or revoked,” with the agency encouraging manufacturers to seek regulatory approval “during the emergency so that [these] devices can remain on the market after the emergency.” FDA’s Center for Devices and Radiological Health (CDRH) announced in October 2020 that it is prioritizing the release in Fiscal Year 2021 of a draft guidance topic titled “Transition Plan for Medical Devices Distributed Under Enforcement Policies or Emergency Use Authorization (EUA) During the COVID-19 Public Health Emergency.”

The Trump administration’s HHS attempted to provide its input on how FDA should regulate devices that have been offered enforcement discretion post pandemic. On January 15, 2021, HHS published a notice and request for information in the Federal Register that: (1) exempted seven glove types from the 510(k) premarket notification requirement, and (2) proposed doing the same to 84 more devices. This action is particularly unusual because, historically, only FDA itself would issue notices related to its 510(k) premarket clearance requirements. It’s not clear from the HHS notice whether FDA was consulted or involved in HHS’s efforts on this matter.

Additionally, as described further below, one of the first actions of the new Biden administration included a White House regulatory freeze memorandum issued on January 20, which has the effect of putting the HHS proposal on hold.

Class I Devices Granted Exemption from 510(k) Premarket Notification

The HHS notice exempted outright the following seven glove types (all Class I devices) from 510(k) premarket notification. Prior to the pandemic, these devices required a 510(k) premarket notice. During the pandemic, FDA is offering enforcement discretion from compliance with the 510(k) requirement.

HHS concluded that, based on a “data-driven review” of adverse events, the lack, or near lack, of adverse events reported in the Manufacturer and User Facility Device Experience (MAUDE) database for these seven devices during the public health emergency shows that the devices no longer require 510(k) premarket notification to provide reasonable assurance of their safety and efficacy. Because the seven devices are Class I devices, per Section 510(l)(2)(A)-(B) of the Federal Food Drug and Cosmetic Act (FFDCA), no public notice period is required and the devices are deemed exempt from the 510(k) premarket notification requirement upon publication of the notice in the Federal Register. The devices will continue to be subject to FDA’s general controls (e.g., registration and listing, labeling requirements, QSR, MDR, reporting of corrections/removals).

Devices Proposed to be Exempt from 510(k) Premarket Notification

Importantly, the HHS notice also proposed exempting 83 Class II devices and one unclassified device from the 510(k) premarket notification requirement. Some of the devices included in the proposal are as follows:

Using as a rationale that there has been a lack of reported adverse events associated with these devices since the grant of enforcement discretion, HHS claimed that the 510(k) premarket notification requirement is not required to provide reasonable assurance of the safety and efficacy of these 84 devices; FDA’s general controls are sufficient. As required under Section 510(m)(2) of the FFDCA, that proposal was supposed to go through a 60-day notice and comment period before a determination to remove the 510(k) premarket notification requirement could be made.

In addition to public comments solicited regarding the specific 84 medical devices, the notice also requested comments, research, and analysis on whether other medical devices should be exempted from premarket review.

What Can Industry Expect Next

On the first day of the Biden administration, the White House circulated a memorandum to all heads of executive departments and agencies halting activities for rules that have been published in the Federal Register but have not taken effect. Agencies are requested to delay the rulemaking process for 60 days to allow for incoming officials to review any questions of fact, law, and policy that the rules or policies may raise. If there are no questions, no further action will be required, and the relevant rule or policy will be considered effective. By contrast, for rules or policies that raise substantial questions, agencies are to notify the director of the Office of Management and Budget (OMB) and take further action in consultation with the OMB director.

Therefore, as a result of the Biden administration’s action, the proposed rulemaking has been halted for now.

Ultimately, we think it is unlikely that the Biden administration will move forward with the proposed rulemaking because the rationale offered by the Trump administration is questionable. Specifically, there are inherent limitations with utilizing MAUDE data to evaluate the safety profile of a device.

• Every event in which a device may have caused or contributed to a death or serious injury is not reported to FDA.
• Manufacturers and initial importers—which are required to report events to FDA of which they become aware that reasonably suggest that their device may have caused or contributed to a death or serious injury—may fail to do so either unintentionally or due to the lack of having robust procedures and processes. For example, FDA issued on October 7, 2020 a Warning Letter to Battelle Memorial Institute, the holder of an EUA for a decontamination system for N95 respirators, for failing to establish procedures and processes for reporting events to FDA.
• New market entrants using enforcement discretion to promote a device for the first time may not have had time to fully establish FDA reporting procedures and processes.

Although there may be arguments for certain of the Class II devices on the list to be exempt from 510(k) notification (e.g., gowns, oximeters), it is hard to imagine HHS and FDA under the Biden administration no longer requiring 510(k)s for higher-risk devices (e.g., ventilators, digital imaging software).

HOW WE CAN HELP

Morgan Lewis helps companies around the world and across industries assess the impact of the legal and regulatory issues described above. We have assisted numerous clients with navigating FDA policies and guidance related to medical device and digital health products, both before and during the COVID-19 pandemic, including support for evaluating how or whether such technologies are regulated by FDA, the preparation and submission of EUAs, and other premarket submissions. We also counsel companies on postmarket compliance, including the development of quality system procedures and the preparation/defense of companies before FDA inspections.

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CONTACTS

If you have any questions or would like more information on the issues discussed in this LawFlash, please contact any of the following Morgan Lewis lawyers:

Washington, DC
Dennis Gucciardo
Michele Buenafe