USA – Device, digital health firms oppose HHS’ proposed 510(k) exemptions

Medical device and digital health companies have largely come out in opposition to a proposal from the Department of Health and Human Services (HHS) to permanently exempt 84 types of medical devices from premarket notification (510(k) requirements.
The proposal was made in the final days of the Trump administration and was pushed through without consulting the US Food and Drug Administration (FDA), the agency that would typically issue such a notice. All the devices included in the proposal, which include 83 Class II devices and one unclassified device, were temporarily exempted from premarket review requirements during the COVID-19 public health emergency (PHE). (RELATED: HHS pushes through last-minute policies impacting FDARegulatory Focus 12 January 2021).
While the timing of the proposal and the methodology employed to justify exempting the devices from 510(k) requirements have come under fire, it is not uncommon for FDA to exempt devices from 510(k) requirements and the agency is tasked with reviewing whether Class I and II devices should be exempted every five years under the 21st Century Cures Act