FDA Seeks Input on Device Accreditation Pilot
By Michael Mezher -
Published 16 May 2017
The US Food and Drug Administration (FDA) on Monday asked stakeholders for input on its planned pilot program for accrediting medical device test laboratories in an effort to boost device makers' ability to rely on conformity to recognized standards to support premarket submissions.
Categories: News, US, FDA, Medical Devices, Submission and registration
Tags: Accreditation Scheme for Conformity Assessment, ASCA, MDUFA IV, Consensus Standards