UPDATE: Trump Administration’s Midnight Rulemaking to Exempt Certain Class I and II Devices from 510(k) Requirement Rescinded

In a not-so-unexpected turn of events, the Biden-Harris administration’s Department of Health and Human Services (HHS) and the US Food and Drug Administration (FDA) rescinded a notice issued by the Trump administration’s HHS days before leaving office exempting seven glove types from 510(k) premarket notification and proposing to do the same for 84 other devices ranging from gowns to ventilators.

As we previously explained in a LawFlash, we questioned HHS’s rationale for removing the 510(k) notification based solely on the lack, or near lack, of adverse events reported in the Manufacturer and User Facility Device Experience (MAUDE) database for these devices. All the devices identified in the January 15 rulemaking are currently subject to enforcement discretion from compliance with FDA regulatory requirements in order to increase production during the COVID-19 pandemic.

To reverse the January 15 rulemaking, HHS and FDA published on April 15, 2021, two Joint Notices: (1) a notice that reinstates the 510(k) requirement for the seven gloves types; and (2) a notice rescinding the proposal to exempt the 510(k) requirement for the one unclassified and 83 Class II devices. In addition to other specific reasons, both Joint Notices provide the following rationales for reversing course:

• Removing the premarket notification requirement based on MAUDE data alone is “flawed” due to “underreporting of events, inaccuracies in reports, lack of verification that the device caused the reported event, and lack of information about frequency of device use.” The Joint Notices explain that adverse event data are “not adequate on [their] own for assessing safety, let alone whether to determine a device to be exempt from 510(k).”
• There was no “evidence that HHS consulted with, otherwise involved, or even notified FDA before issuing the [January 15] Notice,” despite this being required under the Federal Food, Drug, and Cosmetic Act (FD&C Act). Specifically, the Joint Notices explained that the FD&C Act “provides that the Secretary ‘shall be responsible for executing’ the FD&C Act ‘through the [FDA] commissioner.’” Therefore, FDA involvement is required in order to remove the premarket notification requirement. Finally, the Joint Notices explain that FDA must have some level of involvement in removing the premarket notification requirement because they are the subject matter expert for determining whether reasonable assurances of safety and effectiveness can be provided without requiring a 510(k) submission.

Warning to Glove Manufacturers that Relied on the Trump Administration’s Rulemaking

Because the January 15 notice went into effect for the seven glove types (but not for the other 84 devices), the relevant Joint Notice explains that it expects any manufacturers that may have relied on the January 15 notice to immediately comply with the 510(k) requirement. The Joint Notice warns industry that FDA will increase its enforcement efforts with respect to these gloves. Specifically, the Joint Notice indicates FDA will increase labeling review and physical examination of the gloves for defects, in particular at ports of entry to ensure that no gloves that have not been cleared by FDA enter the US market.

FDA/HHS Coordination Efforts

Although the Biden-Harris administration’s action is not unexpected, the Joint Notices provide the public with a glimpse into the coordination efforts (or lack thereof) of the Trump administration’s HHS and FDA. There were other instances during the pandemic where industry questioned whether former President Trump’s HHS and FDA were acting in concert with one another (see, for example, our LawFlash on HHS’s August 19, 2020 proclamation revoking FDA’s jurisdiction over laboratory developed tests, or LDTs). Under the Biden-Harris Administration (as witnessed through the issuance of the Joint Notices), we expect general coordination between HHS and FDA.

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