In the notice, HHS and FDA said they “did not find any evidence that HHS consulted with, otherwise involved, or even notified FDA before issuing the Notice.” They stressed that consultation with FDA is not only required for implementing an exemption under the Federal Food, Drug, and Cosmetic Act (FDC Act) – which provides that HHS shall be responsible for executing the statute through the FDA Commissioner – but also critical in that FDA has the expertise needed to properly evaluate whether a 510(k) submission is necessary to assure the safety and effectiveness of a device. Further, HHS and FDA determined upon review that “the proposed exemptions in the January 15, 2021, Notice were published without adequate scientific support, that the Notice contained errors and ambiguities, and that the Notice is otherwise flawed.” Accordingly, the government said it is withdrawing the proposed exemptions of the 83 class II devices and 1 unclassified device that was published on January 15.
Specifically, the April 16 notice cited the inappropriate reliance on adverse events reported in FDA’s MAUDE database – and a limited selection of such events, i.e., only those categorized as death-related – as the sole basis for exempting the specified device types. As recognized in the January 15, 2021, Notice itself, as well as in numerous public comments submitted in response to it, adverse event reports are a valuable source of information to consider in regulatory decision-making, but are far from comprehensive in representing a device’s safety profile. FDA wrote in last week’s notice that, like any “passive surveillance system,” MAUDE has “limitations, including the potential submission of incomplete, inaccurate, untimely, or biased data.” Additionally, “incidence or prevalence of an event cannot be determined from this reporting system alone due to under-reporting of events, inaccuracies in reports, lack of verification that the device caused the reported event, and lack of information about frequency of device use.” Relatedly, we noted in our January client alert that there were issues with HHS’s January proposal relying on the MAUDE database, because several medical devices listed in the notice have only begun to be sold in the past few years; and furthermore, FDA did not specifically describe for the new players in the market due to the COVID-19 public health emergency how they should report adverse events until September 9, 2020, at which time FDA required companies to set up an eMDR account, which can be a complex process.
Beyond the limitations of MAUDE data in illustrating the overall risks posed by a particular device type, the April 16 notice stressed that a decision to exempt a device from 510(k) requirements must be based on a determination that premarket clearance is not required to provide an adequate assurance of safety and effectiveness – the latter of which is not addressed at all by examining adverse event reports. More broadly, HHS and FDA emphasized that FDA has long examined four factors that take into account both safety and effectiveness in making exemption determinations; specifically, whether: (1) there is notable history of false or misleading claims or of risks associated with inherent characteristics of the device; (2) any device characteristics necessary for the device’s safe and effective performance are well established; (3) any changes in the device that could affect safety and effectiveness will (a) be readily detectable by users by visual examination or other means such as routine testing, before causing harm, or (b) not materially increase the risk of injury, incorrect diagnosis, or ineffective treatment; and (4) any changes to the device would not likely result in a change in its classification. However, these factors were not considered as part of the January 15, 2021 Notice.
Many of the Product Codes that were proposed for exemption, such as those for several software-based devices, were only recently created through the de novo pathway; accordingly, factor number two is clearly not met for those device types. Moreover, many of the COVID-19 policies which the January 15, 2021 Notice referenced as having exempted specified device types from 510(k) requirements in fact only exempted certain modifications to already-cleared devices in those Product Codes that would ordinarily require a new 510(k). Therefore, comparing adverse events before and after declaration of the public health emergency for those Product Codes would not accurately depict whether removal of a 510(k) requirement impacts safety and effectiveness, since new devices in those Codes continued to require 510(k) clearance.
The April 16 notice stated that HHS also erred in proposing to exempt the unclassified device type (Product Code LXV, Vestibular analysis apparatus) from 510(k) requirements, because such devices are not eligible for exemption under the FDC Act provision in question, and the Notice did not cite to any other statutory provision that authorizes exemption of unclassified devices from 510(k) premarket notification.
In this Federal Register Notice, FDA did not override the January 15 exemptions for the seven class I devices, which were all gloves. Rather, HHS and FDA published on the same date a separate Notice and Request for Comment, explaining that the class I devices that are the subject of the January 15, 2021, Notice meet the criteria for reserved class I devices and that it is appropriate to reverse the determination of exemption for those devices. FDA explained that it plans to issue a future notice in the Federal Register containing a final determination regarding the class I medical gloves.
In closing, we note that the issuance of the original notice and HHS’s and FDA’s reversal on this notice is in and of itself unusual, and occurred in the waning days of the last presidential administration. As such, it would have been more surprising, given the flaws in the analysis that underpinned the proposed changes, if HHS and FDA had stuck behind the grant of exemptions for the 84 medical device types, many of which would still be considered new and novel, including some that incorporate artificial intelligence.
Authored by Jodi K. Scott, Blake Wilson, and Suzanne Levy Friedman