Evaluation and Reporting of Age, Race, and Ethnicity Data in Medical Device Clinical Studies!!

FDA Draft guidance for your comments

Medical devices are used by people of not only different geographic variables but also demographic variable like Age, Sex, Race and Ethnicity. The primary intent of this draft guidance us to improve the quality, consistency and transparency of data regarding the performance of medical devices within specific age, race, and ethnic groups.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. The draft guidance includes recommendation and consideration to assist sponsor in developing a strategy to enroll diverse populations including representative proportions of relevant age, race, and ethnicity subgroups, which are consistent with the intended use population of the device.

This guidance is intended for devices that include clinical information in support of a marketing 1submission, whether a premarket notification (510(k)), premarket approval (PMA) application, evaluation of Automatic Class III Designation (de novo request), or humanitarian device exemption (HDE) application. The recommendations contained herein also apply to post-approval study submissions and post market surveillance studies, where noted.

You should submit comments and suggestions regarding this draft document before 09/18/2016.
Submit electronic comments to regulations.gov.
Submit written comments to the “Division of Dockets Management (HFA-305), Food and Drug Administration, 195630 Fishers Lane, rm. 1061, Rockville, MD 20852.”

I More info: Evaluation and Reporting of Age, Race, and Ethnicity Data in Medical Device Clinical Studies
Federal Register Volume 81, Number 118 (Monday, June 20, 2016)

? For any assistance or questions or clarification please contact us at info@mdiconsultants.com or use our Contact form. Ref: MDD Evaluation and Reporting of Age, Race, and Ethnicity Data in Medical Device Clinical Studies!!FDA Draft guidance.