We use cookies to deliver our online services. Details of the cookies we use and instructions on how to disable them are set out in our Cookies Policy. By using this website you agree to our use of cookies. To close this message click close.

FDA Finalizes Guidance on Evaluation and Reporting of Age-, Race-, and Ethnicity-Specific Data in Medical Device Clinical Studies

04 October 2017

Medical Device Alert

On September 12, 2017, the U.S. Food and Drug Administration (FDA) released the final guidance that outlines the agency’s expectations and recommendations for the evaluation and reporting of age-, race-, and ethnicity-specific data in medical device clinical studies.

In recent years there has been increased emphasis by FDA on the need for clinical study populations to be broadly representative of the population in which medical products will be used. The final guidance is intended to help study sponsors develop a strategy for enrolling diverse study populations that will include representative proportions of relevant age, racial, and ethnic subgroups. Depending on the interpretation of the guidance by FDA review staff, the final document may significantly increase the importance of these data for sponsors not already analyzing this type of information. Given the concepts discussed in the final guidance, study sponsors will want to begin discussions with FDA regarding these topics early in the clinical study development process.

Read More: FDA Finalizes Guidance on Evaluation and Reporting of Age-, Race-, and Ethnicity-Specific Data in Medical Device Clinical Studies

Contacts

Loading data