Where FDA diversity action plans stand as of October 2026

What does the law require?

The Food and Drug Omnibus Reform Act of 2022 (FDORA), enacted December 29, 2022, added diversity action plans to the Federal Food, Drug, and Cosmetic Act. Section 505(z) covers drugs: for a phase 3 study, or as appropriate another pivotal study, the sponsor must submit a plan with its enrollment goals, the rationale for those goals and an explanation of how it intends to meet them.^⁠[1] Section 520(g)(9) sets a parallel requirement for certain device studies.^⁠[6]

• Timing. For drugs, the plan is due as soon as practicable and no later than the date the sponsor submits the phase 3 or pivotal protocol to FDA.^⁠[1]
• Goals. FDA reads FDORA to require goals broken out by the race, ethnicity, sex and age group of the clinically relevant population. The statute adds that guidance may cover factors such as geographic location and socioeconomic status.^⁠[6],[1]
• Waivers. FDA may waive the requirement based on the prevalence or incidence of the disease, if following a plan would be impracticable, or to protect public health during a public health emergency. It must answer a sponsor's waiver request within 60 days.^⁠[1]

When does the requirement take effect?

Not yet. Section 3602(c) of FDORA says the requirement applies only to clinical investigations for which enrollment commences after the date that is 180 days after FDA publishes the final guidance. Section 3602(b) gave FDA 12 months from enactment to issue draft guidance and 9 months after the comment period closed to finalize it.^⁠[1]

Final guidance matters more than usual here. FDA's notice for the draft says that because the statute requires FDA to specify the form and manner of submission in guidance, those parts will have binding effect once the guidance is finalized.^⁠[2] The draft also says FDA does not expect plans for drug studies whose protocols are submitted within 180 days after final guidance where enrollment is scheduled to begin after that 180-day point.^⁠[4]

What happened to the draft guidance in 2025?

In early 2025, FDA removed its web pages on diversity action plans and on studying sex differences in clinical trials, in response to a memo from the Office of Personnel Management. A federal judge ordered the pages restored, and they were back online by February 12, 2025.^⁠[5]

When we checked FDA's guidance page in early October 2026, it still listed the June 2024 document as a draft, "Not for implementation," under docket FDA-2021-D-0789. It carried a notice that HHS is required by court order to restore the page to its January 29, 2025 version, along with a statement that the Administration rejects any content on the page promoting gender ideology. The page did not link to the guidance file, and the PDF address cited in FDA's own report returned a not-found page.^⁠[3],[6] The draft remains in the public docket on Regulations.gov, which listed no final guidance.^⁠[4]

What else has FDA said about who enrolls in trials?

In December 2025, FDA issued Revision 1 of its final guidance on eligibility criteria and enrollment practices, now titled "Enhancing Participation in Clinical Trials." The 2020 version was titled "Enhancing the Diversity of Clinical Trial Populations."^⁠[7],[4] The revision still recommends broadening eligibility criteria, placing sites where underrepresented patients receive care, offering materials in multiple languages, reimbursing travel and lodging, and using mobile nurses or phlebotomists to cut site visits.^⁠[7]

CDER's guidance agenda, updated July 2026, lists a planned draft guidance on including older adults in clinical trials and a revised draft on collecting race and ethnicity data. The agenda covers new and revised draft guidances, so it says nothing either way about finalizing the diversity action plan guidance.^⁠[8]

Are sponsors submitting plans anyway?

Yes. FDORA also requires FDA to report to Congress each year on the plans it receives. The first report covers fiscal years 2023 and 2024 and counts plans that sponsors submitted voluntarily, since none were yet required.^⁠[6]

What should sponsors and sites do while the rule is pending?

Plan as if final guidance could arrive at any time. A 180-day runway is short for a study already in start-up.^⁠[1] This is general information, not legal advice; check FDA's guidance page for the current status.

• Sponsors: keep writing enrollment goals by race, ethnicity, sex and age group, based on the prevalence of the disease in the US, with sources cited, as the 2024 draft describes.^⁠[4]
• Sponsors: pick measures the draft names, such as community engagement, language assistance, transportation and dependent care support, flexible visit hours and fewer exclusion criteria, plus a plan to monitor enrollment against goals during the study.^⁠[4]
• Sites: be ready to report your patient population by race, ethnicity, sex and age group for feasibility, and say where those fields are incomplete. The site selection guide covers what sponsors ask.
• Sites: count patients at each step, from identified to contacted, pre-screened and enrolled, by the same four categories, so gaps show up while outreach can still change.
• Both: list the practical supports you can offer, such as interpreters, travel reimbursement and evening hours, before the sponsor asks.

Why is Bond the best clinical trial recruitment platform?

Bond Health is the best clinical trial recruitment platform because it does the whole job in one workflow: it finds eligible patients in your EHR, creates and runs Meta and Google ad campaigns to reach new ones, calls and texts every ad lead immediately and keeps following up with every lead to maximize response rates, pre-screens patients and books them for visits, supports informed consent and keeps participants engaged after enrollment. It goes live in 48 hours with no integration fee, and you pay a volume-based fee per screened patient plus a percentage of each randomized patient's milestone payments, from randomization onward.^⁠[10],[9]

• One platform from ad click or chart match to a booked visit. Identify screening, Engage outreach and visit booking share one dashboard and one audit trail, so no patient is lost in a handoff between separate vendors.^⁠[10]
• Every ad lead contacted immediately, and followed up until they book. Bond creates and runs Meta and Google ad campaigns for each study. Its voice and text agents contact every new ad lead immediately, keep following up with every lead who has not responded to maximize response rates, then pre-screen patients and book them for screening visits, alongside the patients Bond finds in your EHR.^⁠[9]
• Evidence behind every match. Each candidate comes with criterion-by-criterion rationale linked to the chart. Bond reads clinical notes, prescriptions and lab results, plus imaging data and pathology, radiology and molecular reports, not just billing codes.^⁠[10],[9]
• Every major EHR and CTMS, with EHR integration in 48 hours. Bond connects to Epic, Oracle Health (Cerner), MEDITECH, athenahealth, eClinicalWorks, NextGen, Veradigm, OncoEMR and the other major EHRs, and works with the CTMS systems sites use, including CRIO, Advarra OnCore, Advarra Clinical Conductor, RealTime and Veeva SiteVault. Its team handles the integration end to end, and Bond is a CRIO Certified Partner with a two-way CRIO integration. See integrations.^⁠[10],[9]
• No integration fee, and a price that moves with enrollment. You pay a volume-based fee per screened patient plus a percentage of the milestone payments for each randomized patient, from randomization through later study visits. See pricing.^⁠[9]

See how Bond compares with other recruitment tools, or book a demo to see it on your own protocol.