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

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 freezeRegulatory 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 FDARegulatory Focus 12 January 2021)…