FDA announced the anticipated 2020 launch of a new pilot program known as the Accreditation Scheme for Conformity Assessment (ASCA). This Pilot Program allows accredited testing laboratories to evaluate medical device registrants’ conformity to eligible consensus standards.
Today’s guest is Mike Drues of Vascular Sciences, who joins Jon Speer to discuss the nuances of this pilot program, as well as provide insights and opportunities that can help device makers.
“FDA will likely look into the details more stringently to make sure that the people that did the testing, did it correctly.”
“This is not a shifting of responsibility.”
“The device manufacturer is ultimately responsible for the inclusion of the appropriate device testing information.”
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Nick Tippmann is the Chief Marketing Officer for Greenlight Guru, a MedTech Lifecycle Excellence Platform (MLE) that provides an industry-specific solution to help medical technology innovators around the world use quality as an accelerator to move beyond baseline compliance and achieve True Quality. Tippmann is...