CDRH Industry: Announcing Final Guidance and FDA Webinar on Evaluation of Sex-Specific Data in Medical Device Clinical Studies

Today the Food and Drug Administration (FDA) posted a final guidance document, “Evaluation of Sex-Specific Data in Medical Device Clinical Studies.” in combination with the FDASIA Section 907 Action Plan. The FDA’s final guidance outlines specific recommendations for considering sex and other variables during the study design stage, to improve consistency of analysis and reporting of information on demographics in labeling and other public documents. The action plan focuses on three over-arching priorities: Data Quality, Subgroup Participation, and Data Transparency. 

Certain medical products may elicit different responses in women than men and these variables may affect the safe and effective use of medical devices. The FDA’s final guidance outlines specific recommendations for considering sex and other variables during the study design stage, to improve consistency of analysis and reporting of information on demographics in labeling and other public documents.

The final guidance provides recommendations to medical device industry and FDA staff on:

• Enrollment: Recommended methods for designing and conducting clinical studies to encourage enrollment of both sexes.
• Analysis: Recommended methods for analysis of demographic data.
• Reporting: Recommended approaches for reporting of demographic data for device studies in the labeling and other public documents for approved or cleared devices.
• Decision frameworks for sex-specific study design, and for considering sex-specific data when analyzing and interpreting overall study outcomes, including when additional data may be needed.

On August 25, 2014 the FDA will hold a webinar to explain the guidance and to provide an opportunity to ask questions.  Registration is not necessary.

Webinar Details:

Date: August 25, 2014

Time: 3:00 PM – 4:30 PM, Eastern Time
To ensure you are connected, log-in at 2:45 PM.

To hear the presentation and ask questions:  

Dial: 1-888-282-0359; passcode: 7984204

To view the slide presentation during the webinar: https://www.mymeetings.com/nc/join/
Conference number: PW8306676 
Passcode: 798204
Following the webinar, a transcript, recording and slides will be available at: http://www.fda.gov/Training/CDRHLearn/default.htm

Please Note: the slide presentation will also be available at this site on the morning of the webinar.

If you have any questions regarding this guidance, please contact one of the following at FDA/CDRH:

• Jismi Johnson (Biomedical Engineer, ODE), jismi.johnson@fda.hhs.gov
• Lilly Yue (Deputy Director, OSB/Division of Biostatics), lilly.yue@fda.hhs.gov
• Nilsa Loyo-Berrios (Deputy Director, OSB/Division of Epidemiology), nilsa.loyo-berrios@fda.hhs.gov
• Robert Becker (Chief Medical Officer, OIR), robertl.becker@fda.hhs.gov)
• Katie O’Callaghan (Senior Health Science Advisor, OCD), kathryn.ocallaghan@fda.hhs.gov
• The Division of Industry and Consumer Education (DICE) at 1-800-638-2041, 301-796-7100 or dice@fda.hhs.gov

Food and Drug Administration
Center for Devices and Radiological Health