Search Results for FDA pilot program

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CDRH to Launch 'Critical to Quality' Pilot Program By Zachary Brennan - Published 11 September 2017

The US Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) will lead a pilot program to define characteristics of a device that are critical to product quality and how these characteristics are controlled in design and manufacturing prior to the postmarket inspection.

Categories: News, US, CDRH, Medical Devices

Tags: Critical to Quality, FDA pilot program

MDSAP to Continue Past Pilot Phase in 2016 By Zachary Brennan - Published 28 October 2015

Put simply, the Medical Device Single Audit Program (MDSAP) isn't going anywhere when its pilot project ends in 2016, Kim Trautman, associate director, international affairs of the Office of the Center Director of CDRH at the the US Food and Drug Administration (FDA), told attendees of RAPS' Regulatory Convergence on Wednesday.

Categories: News, Asia, Canada, Europe, Oceania, US, Anvisa, EC, FDA, GHTF, Health Canada, IMDRF, MHLW, PMDA, TGA, WHO, Audit, Government affairs, In vitro diagnostics, Manufacturing, Medical Devices, Postmarket surveillance, Regulatory intelligence

Tags: MDSAP, medical device single audit program, FDA pilot program, US FDA, TGA, PMDA