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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...
평범하게 흘러가던 어느 날, 평범함에 대한 고민을 시작했다. '평범함'이란 게 대체 뭘까. 나는 평범한가, 평범하기 위해 노력하는 건가. 평범하기 위해 노력하는 건 평범한가....
The FDA's 510(k) clearance of medical devices is based on proven substantial equivalence with claimed predicate device(s). In concert with the...
The FDA's 510(k) clearance of medical devices is based on proven substantial equivalence with claimed predicate device(s). In concert with the...
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...