In a return to regular order, on April 16, HHS and FDA jointly withdrew a January 15, 2021 proposal issued by HHS under the prior administration recommending wide-spread 510(k) exemptions (the “Notice”). See 86 Fed. Reg. 20167, 20174 (Apr. 16, 2021) (available here and here). The Notice, specifically, proposed exempting 83 Class II devices, ranging from thermometers to digital therapeutics and ventilators, and immediately exempted seven types of Class I gloves. Because the glove exemption was immediate upon issuance of the January Notice, HHS and FDA are issuing a notice and request for comment to reinstate the 510(k) requirements for these devices.
The only thing this group of Class I and II devices had in common was that they were all subject to an FDA enforcement discretion policy issued during the COVID-19 public health emergency. See. 86 Fed. Reg. 4088 (Jan. 15, 2021). In brief, the January Notice determined that because these devices were granted regulatory flexibility during the public health emergency that they should be permanently exempt from the 510(k) notification requirements (even if that’s not what the enforcement policy said). In support of this proposal, the Notice looked only to FDA’s publicly available device adverse event database, FDA’s Manufacturer and User Facility Device Experience (MAUDE), to identify any safety risks. Anyone in industry who has ever tried to argue to FDA that a device that is commercially available outside the U.S. should be cleared because there have been no or minimal adverse events knows how willing FDA is to accept lack of adverse events as a sign of safety (for those who haven’t tried this argument, it’s not a winning one).
When this author read the January Notice, it seemed like an ill-thought-out proposal. But, it was actually a gift in waiting having led to what can only be described as two scathing withdrawal notices issued last week, in which HHS and FDA found that “the proposed exemptions . . . were published without adequate scientific support, . . . contained errors and ambiguities, and . . . [were] otherwise flawed.” The Federal Register notice announcing the withdrawal also noted that the enforcement policies that the previous administration proposed expanding and making permanent, “were issued in response to a highly unusual set of facts and circumstances; the most sweeping [public health emergency] to occur in over a century.”
It should not come as a surprise to anyone that at a time when FDA, particularly CDRH, is experiencing an unprecedented workload, it needed to prioritize resources and ensure that it was not a bottle neck to getting devices to people that needed them in a way that minimized risk to the public. It acted by issuing enforcement discretion policies. These policies were never meant to be permanent – each stating that, “This policy is intended to remain in effect only for the duration of the public health emergency related to COVID-19.” Indeed, the glove withdrawal notice goes into detail about the evidence that FDA considers when evaluating a 510(k) exemption for a Class I device noting that if the Agency believed that the gloves met the criteria for exemption it could have issued it, but “instead it chose an enforcement policy, which reflected FDA’s careful balancing of the public health considerations in response to the [public health emergency].”
The withdrawal notices also stated that HHS and FDA had received “dozens” of inquiries, both formal and informal, about the proposal highlighting confusion around ambiguities and errors in the proposal. Interestingly, public comments in response to the January Notice were mixed with some supporting the proposal for specific device types (e.g., digital pathology devices) and others opposing the proposed exemption. The comments in opposition highlighted risks to public health, the methodology for identifying those devices for exemption, and the industry confusion that could be caused if the proposal were to be finalized. The government appeared to agree on the methodology point, stating that “adverse event data is not adequate on its own for assessing safety, let alone whether to determine a device to be exempt from 510(k).”
Many in industry found the January Notice odd given that it came from HHS, rather than FDA. Indeed, in the withdrawal notices, HHS and FDA noted that they “did not find any evidence that HHS consulted with, otherwise involved, or even notified FDA before issuing” the proposed exemptions. The withdrawal made quite clear how HHS and FDA should work together stating, “Section 1003(d) of the FD&C Act (21 U.S.C. 393(d)) provides that the Secretary ‘shall be responsible for executing’ the FD&C Act ‘through the [FDA] Commissioner.’ Here, the January 15, 2021, Notice is clearly an action ‘executing’ the FD&C Act.”
Because the January Notice merely proposed an exemption for the 83 Class II devices, HHS and FDA were able to withdraw it immediately. Thus, there is no change to the regulatory status of those devices. As discussed above, HHS and FDA are currently seeking comment on the reinstatement of the 510(k) requirements for these devices. The notice indicates that HHS and FDA, “believe that only a limited subset of regulated entities may have placed legitimate reliance on the January 15, 2021 Notice” and the government is “concerned about the public health risks posed by the exemption.” Glove manufacturers affected by the exemption should beware of the likely reinstatement of the 510(k) requirements. The comment period closes May 17, 2021.