September 1, 2016 | FDA Office of Minority Health
CDRH DRAFT GUIDANCE WEBINAR
Join us on Monday, September 12, 2016 from 12 pm – 1 pm EST to learn about a new draft guidance from FDA's Center for Devices and Radiological Health (CDRH) on how to evaluate and report age, race, and ethnicity data in medical device clinical studies. You can register and find more information about the webinar on the Eventbrite page.
Earlier this summer, CDRH issued a draft guidance document to outline FDA's proposed recommendations and expectations for the evaluation and reporting of age, race, and ethnicity data in medical device clinical studies. The primary intent of these recommendations is to improve the quality, consistency, and transparency of data regarding the performance of medical devices within specific age, race, and ethnic groups. Proper evaluation and reporting of this data can benefit patients, clinicians, researchers, regulators and others. Additionally, it is important that clinical trials include diverse populations that reflect the intended use population. This draft guidance includes recommendations and considerations to assist sponsors in developing such a strategy.
Comments on the document will be accepted until September 19, 2016. Click here to leave your comment and to review the document.