ARTICLE SUMMARY:
The agency has republished its sex-specific guidance, with deletions. Excerpted from Pathways’ Picks April 2: FDA Hit Hard by Layoffs, LDT Regulation is Dead, Global “Reliance” Plan Floated.
FDA published a new final guidance document titled “Evaluation of Sex-Specific Data in Medical Device Clinical Studies” that backtracks on a prior effort to incorporate gender as a distinct consideration from sex, and makes other deletions. The guidance was originally published in 2014, to lay out a more structured framework for companies to consider distinctions and appropriate clinical study enrollment, in part to address under-representation by women in research. In early January 2025, FDA issued an updated draft that attempted to distinguish between “sex-specific” and “gender-specific” considerations for studies. In response to a January 20 executive order from President Trump outlawing discussion of gender identity by federal agencies, FDA took down the draft from its website. The new final guidance hews relatively closely to the 2014 document, including an untouched decision-framework flowchart. However, FDA deleted various phrases, including any mention of the word “gender,” any reference to ethnic or racial groups as factors that should also influence study enrollment, and several other statements.