Regulatory Impact Brief: Impact of President Trump's DEI Order on FDA Submissions and Rules
The recent federal mandate limiting Diversity, Equity, and Inclusion (DEI) initiatives is expected to affect FDA medical device regulations, particularly in clinical trial requirements and demographic considerations. Additionally, any unfinalized rule changes are currently paused, with uncertainty about their return.
Key FDA Guidances and CDRH Initiatives Impacted
The following guidance documents and initiatives have been removed from the FDA website:
FDA Guidance – Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies
FDA Guidance – Evaluation of Sex-Specific and Gender-Specific Data in Medical Device Clinical Studies
CDRH – Office of Equity and Innovative Development (previously responsible for advancing health equity, patient engagement, and innovation initiatives)
FDA Guidance – Evaluation and Reporting of Age, Race, and Ethnicity-Specific Data in Medical Device Clinical Studies
(Note: The finalized version of this guidance remains active, but FDA’s interpretation of study data may shift.)
It remains unclear whether these changes are permanent or temporary.
What This Means for You
Diversity Action Plans will likely no longer be required for marketing applications
Less emphasis on demographic diversity in trials, potentially affecting trial design and FDA review
Reduced funding and focus on equity programs for underserved populations
Organizations should monitor regulatory updates and prepare for possible shifts in FDA expectations regarding clinical study design and data interpretation.