Global Medical Device Podcast Powered By Greenlight.guru

What are the pros, cons, and ramifications of the U.S. Department of Health and Human Services’ (HHS) proposal that impacts the medical device industry?In this episode of the Global Medical Device Podcast, Jon Speer talks to Mike Drues from Vascular Sciences about the HHS proposal, which focuses on down-classifying and exempting more than 80 types of devices such as exam gloves, thermometers, imaging systems, infusion pumps, and ventilators.Some highlights of this episode include:In January 2021, HHS declassified a number of medical devices without first consulting or notifying FDA. As a result, the reclassification initiative is on hold pending a review due to regulatory freeze.The HHS proposal affects seven (7) Class I devices (all gloves) and eighty-three (83) Class II devices, such personal protective equipment (PPE) and thermometers.It’s ironic that regulatory quality requirements apply to products but don’t seem to apply to processes that regulate those products. It’s another example of not practicing w