- October 31, 2017
08:00 AM - 09:30 AM EDT
On Tuesday, October 31, 2017, the FDA hosted a webinar to share information and answer questions about the final guidance document, “Evaluation and Reporting of Age, Race, and Ethnicity Data in Medical Device Clinical Studies.” This final guidance document provides recommendations to improve the quality, consistency and transparency of data on how medical devices perform within specific age, race, and ethnic groups. Proper evaluation and reporting of this data can benefit patients, clinicians, researchers and regulators.
If you have any questions, please contact the Division of Industry and Consumer Education (DICE) in the Center for Devices and Radiological Health (CDRH) at 1-800-638-2014, 301-796-7100 or firstname.lastname@example.org.