Search Results for final FDA guidance

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CDRH Finalizes Guidance on Reporting Age, Race and Ethnicity Data in Studies Published 12 September 2017

The final guidance outlines FDA’s recommendations and expectations for patient enrollment, data analysis, and reporting of age, race and ethnicity data in medical device clinical studies.

Categories: News, US, CDRH, Clinical, In vitro diagnostics, Medical Devices

Tags: medical devices, final FDA guidance

FDA Finalizes Guidance on Adaptive Designs for Device Studies By Zachary Brennan - Published 26 July 2016

The US Food and Drug Administration (FDA) on Tuesday finalized guidance that lays out how to design medical device clinical trials that allow for changes based on data, while maintaining study validity and integrity.

Categories: News, US, FDA, Due Diligence, Medical Devices, Research and development

Tags: adaptive trial designs, device clinical trials, final FDA guidance