FDA Reverses HHS Exemption of Class I and Class II Medical Devices from Section 510(k)

• Published date: 21 April 2021
• Subject Matter: Exemptions,Medical Devices,Public Notice,FD&C Act,Department of Health and Human Services (HHS),Federal Register,Public Health Emergency,Pre-Market Notification,FDA
• Author: Elaine Tseng,Jessica Ringel,Steven Niedelman,Elizabeth Schmidtlein Crockett
• Law Firm: King & Spalding