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[Music] hello and welcome to guidance review im david pudwill and today were going to be talking about fdas recent guidance document on the asca pilot thats the accreditation scheme for conformity assessment which was recently published in september of 2020. there are a few key takeaways id like you to get out of todays video the first is to understand the purpose and specific goals of the asca pilot the second is to understand the development of the asca pilot and finally the roles and responsibilities for those involved so with that lets go ahead and get into todays guidance document here we have on fdas website the current final guidance document we see here we can download the final guidance we can read the federal register notice and we can head over to the docket here and this particular guidance as we can see here and elsewhere is issued by the center for devices in radiological health as well as the center for biologics evaluation and research and theres some high le