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