FDA Reverses HHS Exemption of Class I and Class II Medical Devices from Section 510(k)
By EsqSocial Corporation 21/04/21
Premarket Notification Again Required for Patient and Surgeon's Examination Gloves and Dozens of Class II Devices Proposed for Exemption by Former HHS Secretary - On April 16, 2021, the Food and Drug Administration (“FDA” or “the Agency”) took action to reverse a last-minute Federal Register notice published by the outgoing Trump Administration Secretary of Health and Human Services (“HHS”) on January 15, 2021 (the “January 15 HHS Notice”)......
By: King & Spalding