FDA Announces Draft Guidance on Sex- and Gender-Specific Data in Medical Device Studies
January 07, 2025
January 07, 2025
WASHINGTON, Jan. 7 (TNSFR) -- The U.S. Food and Drug Administration (FDA) has released a draft guidance document aimed at improving the evaluation of sex- and gender-specific data in medical device clinical studies.
The draft guidance encourages medical device developers to consider sex and gender factors in clinical investigations to ensure the safety and effectiveness of devices across diverse populations. This document also addresses the historical underrepresentation of women an . . .
The draft guidance encourages medical device developers to consider sex and gender factors in clinical investigations to ensure the safety and effectiveness of devices across diverse populations. This document also addresses the historical underrepresentation of women an . . .