ARTICLE SUMMARY:
DEI-related documents have been pulled from the agency’s website. Excerpted from Pathways’ Picks January 29: FDA Docs Removed, Resignations Requested, Acting Commish, Global Picks, and More.
FDA last week took down an array of documents and pages from its website primarily connected to diversity, equity, and inclusion (DEI)-related efforts. The excisions are likely the result of President Trump’s January 20 Executive Order to end federal DEI programs. It also coincides with an announced “pause on mass communications and public appearances that are not directly related to emergencies or critical to preserving health.” Key device-related guidance and other documents that can no longer be viewed on FDA’s website include, with Internet Archive or other non-FDA links to the originally posted item:
- FDA’s June 2024 draft guidance on Diversity Action Plans: The draft laid out how FDA intends to implement a legislative mandate for device and drug firms to submit diversity action plans for clinical trials. Some companies have already voluntarily started submitting DAPs, and the requirement doesn’t take effect until six months after a guidance is finalized. Also, the Federal Register notice linked to this draft guidance remains online.
- January 2025 draft guidance on evaluation of “sex-specific and gender-specific data” in device studies: This draft primarily sought to add a distinction between “gender” and “sex” and incorporate categories including nonbinary and transgender as considerations for designing studies. The original final guidance the draft was supposed to update, which just focuses on “sex-specific data” remains on FDA’s site.
- January 2024 draft guidance on the collection of race and ethnicity data in clinical studies: This draft addresses studies for all varieties of medical products. The relevant Federal Register notice remains online.
- An August 2024 discussion paper on Health Equity for Medical Devices: CDRH sought public comments last year on these proposals to improve equity by addressing the design and analysis of studies.
- CDRH’s 2022-2025 Strategic Priorities: The document, intended to guide the device center’s overarching priorities through the end of this year, emphasizes promoting a “modern and diverse workforce” and advancing health equity as two of its three focus areas.
- CDRH’s Health of Women Program website: The program “has been working towards a better understanding of how medical devices perform in women and exploring unique issues in the regulation of medical devices related to the health of women.”
- CDRH’s 2024 Annual Report: Published on January 17, the report generally summarized the device’s accomplishments from last year.