Search Results for Consensus Standards

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CDRH Clarifies Process for Consensus Standard Recognition Requests By Michael Mezher - Published 20 July 2017

The US Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) this week detailed changes to its process for handling requests for the agency to recognize new voluntary consensus standards for medical devices, as required by the 21st Century Cures Act.

Categories: News, US, FDA, Medical Devices

Tags: Consensus Standards, 21st Century Cures Act

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