FDA update December 19, 2011

Draft Guidance for Industry: Evaluation of Sex Differences in Medical Device Clinical Studies

This Draft guidance is intended:

• To guide on the study and evaluation of sex differences in medical device clinical studies.
• To outline the Center for Devices and Radiological Health’s (CDRH) expectations regarding sex-specific patient enrollment, data analysis, and reporting of study information.
• To improve the quality and consistency of available data regarding the performance of medical devices in both sexes by ensuring appropriate representation by sex in clinical studies of devices, and that data from such studies is appropriately analyzed for sex differences. This information can be of benefit to patients and their medical providers, as well as clinical researchers and others.
• To provide recommendations for study design and conduct to encourage enrollment of women in proportions that are representative of the demographics of disease distribution
• To outline recommended statistical analyses of study data for sex differences, and to identify sex-specific questions for further study
• To encourage the consideration of sex and associated covariates (e.g., body size, plaque morphology, etc.) during the study design stage  
• To specify CDRH’s expectations for reporting sex-specific information in summaries and labeling for approved devices.
• This guidance is intended for devices that require clinical information in support of a marketing submission, whether a premarket notification (510(k)), premarket approval (PMA) application or humanitarian device exemption (HDE) application.
• The recommendations contained herein also apply to post-approval study (PAS) submissions and post market surveillance (PS) studies conducted in accordance with Section 522 of the Food, Drug and Cosmetic Act., where noted. Sex is not the only demographic variables which may have an impact on device performance.

PLEASE BE AWARE THAT THIS IS YOUR CHANCE TO MAKE YOUR THOUGHTS TO BE KNOWN: Written comments and suggestions may be submitted at any time for FDA  consideration to the Division of Dockets Management, Food and Drug Administration, 5630  Fishers Lane, Room 1061, (HFA-305), Rockville, MD, 20852. When submitting comments, refer to Docket No. FR DOC #: 2011-32368

Or you can send your comments before March 19, 2012at info@mdiconsultants.com and REF: Evaluation of Sex Differences.

For more information on this guidance you can go to the following link: http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM283707.pdf