Essential Performance News Today

The U.S. Food and Drug Administration (FDA) recently issued the final guidance, “Electromagnetic Compatibility (EMC) of Medical Devices: Guidance for Industry and Food and Drug...

Apr 7th, 2021 A 2020 FDA guidance may soon help boost consistency in medical device testing and expedite review of submissions for eligible devices. At MD&M BIOMEDigital, Chris Parker, head of in-vivo biocompatibility at Toxikon, explained that in Sept. 2020, FDA published final guidance on Accreditation Scheme for Conformity Assessment (ASCA),  launching a program where labs that perform testing for ISO 10993—Biocompatibility and IEC 61010/IEC 60601–Basic Safety and Essential Per...