FDA update December 19, 2011
Draft Guidance for Industry: Evaluation of Sex Differences in Medical Device
This Draft guidance is intended: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
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
firstname.lastname@example.org and REF: Evaluation of Sex Differences.
For more information on this guidance you can go to the following link: