Silver Spring, September 2017.  FDA finalized guidance drafted in June 2016 regarding its recommendations and expectations for age, race, and ethnicity evaluation and reporting in medical device clinical studies this week.  The guidance addresses subject enrollment, data analysis, and reporting during medical device clinical study design, outcomes, and summaries and labeling for approved or cleared devices.  For a complimentary copy of the final guidance click here or, if you would like to discuss your clinical trial needs, or, to receive more updates like this one, and possibly

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