🏛️Notice of Cooperative Studies Scientific Evaluation Committee Meeting
The Department of Veterans Affairs announces a virtual meeting of the Cooperative Studies Scientific Evaluation Committee, where expert advice on VA cooperative studies and clinical research will be provided. The meeting will include a public session followed by a closed session for discussions on research applications and related matters. Attendance details for the open session are provided.
Learn More⚖️FDA Guidance on Sex-Specific Data in Medical Device Studies
The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled "Evaluation of Sex- Specific and Gender-Specific Data in Medical Device Clinical Studies." This document provides guidance on the study and evaluation of sex- and/or gender-specific data in clinical investigations or research involving one or more subjects to determine the safety or effectiveness of a device. The purpose of this guidance is to encourage science- driven consideration of sex and/or gender, as appropriate for both the scientific question being addressed and the intended use of the device, when designing medical device clinical studies and reporting data from such studies in accordance with legal requirements. This draft guidance is not final nor is it for implementation at this time.
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