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FDA To Ramp Up ASCA Pilot In 2021

A report from the US FDA says the agency will focus on updating its premarket submission portal, training staff and taking additional steps to start taking in applications for ASCA pilot participant sponsors.

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The US Food and Drug Administration will be ramping up its work to realize the Accreditation Scheme for Conformity Assessment (ASCA) this year, a new agency report says. In particular it will be focusing on trying to recruit sponsors for its pilot program, train agency staff and update its premarket submission portal to accommodate the program.

Development of ASCA was an important part of the agreement between the FDA and the medtech industry in the last...

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