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 testing performed to recognized standards at these accredited labs may be submitted with only a summary report instead of a full report (if no unexpected results occur) and they can expect an expedited review during submission.