FDA Issues Guidance for Evaluation of Sex-Specific Data in Medical Device Studies

August 22, 2014—In the Federal Register, the US Food and Drug Administration (FDA) announced that the final guidance document “Evaluation of Sex-Specific Data in Medical Device Clinical Studies” is now available online. In June, the FDA announced that the agency was finalizing this guidance document as part of its initiative to improve an “information gap” that contributes to the issue of a low number of women enrolling in some clinical trials for medical devices.

The document outlines the Center for Devices and Radiological Health’s (CDRH’s) and Center for Biologics Evaluation and Research’s (CBER’s) expectations regarding sex-specific patient enrollment, data analysis, and reporting of device study information.

According to the FDA, the guidance is intended to improve the quality and consistency of available data regarding the performance of medical devices in both sexes by encouraging appropriate enrollment by sex in clinical studies of devices and appropriate interpretation and assessment of data from such studies analyzed by sex. Evaluation of sex-specific data in medical device clinical studies can benefit patients, their medical providers, clinical researchers, and others.

The specific objectives of this guidance are to:

1. Encourage the consideration of sex and associated covariates (eg, body size, plaque morphology, etc.) during the study design stage;

2. Provide recommendations for study design and conduct to encourage appropriate enrollment of each sex (eg, in proportions generally representative of the demographics of disease distribution, if appropriate);

3. Outline recommended sex-specific statistical analyses of study data with a framework for considering sex-specific data when interpreting overall study outcomes; and

4. Specify FDA’s expectations for reporting sex-specific information in summaries and labeling for approved or cleared medical devices.

In December 2011, FDA announced the availability of the draft guidance document.

In response to the multiple comments with recommendations pertaining to the evaluation of sex-specific data in clinical studies, FDA revised the guidance document to clarify the processes of sex-specific data evaluation in clinical studies and policies as appropriate. For more clarity, a decision framework for different clinical study designs was added to the guidance in response to comments received requesting additional information on when various sex-specific statistical recommendations would apply. Additionally, several comments requested that the recommendations in the guidance apply to the demographic subgroups of age, race, and ethnicity. This is outside of the scope of the revised guidance, but, where applicable, the guidance was updated with links to other guidances and information related to these other demographic subgroups, advised the FDA.