- Docket Number:
- Issued by:
Guidance Issuing OfficeCenter for Devices and Radiological Health
This document provides guidance on the study and evaluation of sex-specific data in medical device clinical studies. The purpose of this guidance is to outline the FDA’s expectations regarding sex-specific patient enrollment, data analysis, and reporting of study information. The primary intent is 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 that data from such studies is appropriately analyzed by sex. This information can be of benefit to patients and their medical providers, as well as clinical researchers and others.
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All written comments should be identified with this document's docket number: FDA-2011-D-0817.