HHS’ proposed 510(k) exemption proves the need for regulatory science

Regulatory NewsRegulatory News | 05 April 2021 |  By 

Authors of a recent commentary in Nature Medicine have come out against a federal notice that would exempt more than 91 medical devices from premarket notification 510(k) requirements.
The notice, released by the Department of Health and Human Services (HHS) on 15 January, was published in the last days of the Trump administration without consulting the US Food and Drug Administration (FDA). It is currently on hold pending review per a “regulatory freeze” memorandum issued by White House Chief of Staff Ronald Klain on 20 January. (RELATED: Biden’s day one regulatory freeze, Regulatory Focus 21 January 2021).
The proposal would make permanent an exemption for seven Class I medical devices during the COVID-19 pandemic, all of which were gloves. It also proposed permanent exemptions from 510(k) notification requirements for 83 Class II medical devices and 1 unclassified device, which include personal protective equipment, thermometers, imaging systems, infusion pumps, ventilators and devices related to artificial intelligence. (RELATED: HHS pushes through last-minute policies impacting FDA, Regulatory Focus 12 January 2021).
Commenting on the federal notice, Jochen Lennerz, of the Department of Pathology, Center for Integrated Diagnostics at Massachusetts General Hospital in Boston, and colleagues argued that the decision to remove oversight by FDA “sends an alarming message—that regulatory science and applying its principles during regulatory review are unnecessary.”
The claim in the notice that the lack of FDA-reported adverse events for the devices in question is evidence that they are safe for use is “arguably unproven,” the authors said, noting that the FDA review process and other attributable factors could be responsible. “[S]imply put, the safety of the current devices driving the removal might be in part attributable to those devices having undergone independent, scientifically sound FDA review.”
“The proposed permanent changes thereby represent a manifestation of the principle that ‘nobody ever gets credit for fixing problems that never happened’; however, it is exactly in this context that regulatory science, with its diverse tools, standards and approaches, is necessary to ensure safety, efficacy, quality and performance to help prevent adverse events,” they wrote.
Lennerz and colleagues pointed out that regulatory science, while encouraged by FDA, is not limited to the organization and has created a “regulatory ecosystem” consisting of scientists with “methods, tools and standards to facilitate and inform regulatory decision-making.” This ecosystem gathers stakeholders to address issues like regulating difficult areas, such as in artificial intelligence and generative adversarial networks where tools are constantly learning and changing.
“In other words, the federal notice highlights the exact purposes for which regulatory science exists—namely, that rigorous review of passive event-reporting systems and long-term monitoring to elucidate causal relationships of adverse events is necessary,” they wrote.
Lennerz and colleagues argued that the combination of logical oversight and valid scientific evidence is required for the acceleration of medical innovation inside and outside the FDA, and that the use of regulatory science tools and scientific evidence inside a regulatory framework is “paramount” for delineation of complex medical devices.
“Regulatory science has concrete patient-care, societal and economic consequences. Estimating the unintended and potentially costly consequences of this federal notice and its elimination of applied regulatory science requires more than commenting or lobbying. It requires science—regulatory science,” they concluded.
The authors of the Nature Medicine commentary are not the first to criticize the HHS notice—medical device and digital health companies have largely called for a return to pre-pandemic regulation or to seek solutions other than premarket notification requirement exemption for these devices. (RELATED: Device, digital health firms oppose HHS’ proposed 510(k) exemptions. Regulatory Focus 23 March 2021).
Nature Medicine


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Tags: 510(k), FDA, US

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