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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 Performance can become accredited by the FDA. The key ASCA takeaway for manufacturers is that the tes...