Search Results for Consensus Standards

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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

FDA Re-Recognizes Three Radiology Consensus Standards By Alexander Gaffney, RAC - Published 14 May 2014

Categories: US, FDA, CDRH

Tags: Radiology, Consensus Standards, IEC, Latest News