The Food and Drug Omnibus Reform Act of 2022 (FDORA) added a statutory requirement that sponsors of certain clinical studies submit a Diversity Action Plan to the FDA — a document setting out enrollment goals for the trial’s target population, broken out by age group, sex, race, and ethnicity, along with the sponsor’s rationale for those goals and its plan for meeting them. This page explains what the requirement actually says, which studies it covers, what has to be in a plan, and — because this is a case where the underlying law and the FDA’s implementing guidance have not moved in lockstep — where the guidance itself currently stands.
Because FDA.gov’s own guidance pages for this topic have proven unreliable to link to directly (the document was pulled from the agency’s site in early 2025 and its exact current URL and status have shifted more than once — see the status section below), the specifics on this page are corroborated against law-firm and health-policy secondary sources that tracked the guidance in real time, flagged as REPORTED-tier where noted, rather than a single primary citation.
What FDORA actually requires
Section 3601 of FDORA is codified in the Federal Food, Drug, and Cosmetic Act (FDCA) as new Section 505(z) for drugs and biological products, and Section 520(g)(9) for certain devices. The statute requires sponsors of covered studies to submit a Diversity Action Plan (sometimes shortened to “DAP” in industry commentary) that includes, at minimum:
- Enrollment goals for the study’s population, disaggregated by age group, sex, race, and ethnicity;
- The sponsor’s rationale for how those goals were determined, typically grounded in the epidemiology of the condition being studied; and
- An explanation of how the sponsor intends to meet the stated enrollment goals — the operational recruitment and retention plan behind the numbers.
The underlying policy goal, consistent across FDA and sponsor-side commentary, is generalizability: a pivotal trial’s results are only as reliable for a demographic subgroup as the number of that subgroup’s participants actually enrolled, and clinically meaningful differences in safety or efficacy across subgroups can go undetected in a trial population that doesn’t reflect the disease’s real-world demographics.
Which studies are covered
The statute draws the covered-study line differently for drugs/biologics than for devices:
- Drugs and biological products: Phase 3 studies, or other studies the sponsor and FDA agree are “pivotal” to a marketing application — not every study in a development program, and not earlier-phase exploratory work.
- Devices: clinical studies submitted as part of an Investigational Device Exemption (IDE) application, a premarket notification (510(k)), a De Novo request, or a premarket approval (PMA) application.
Early-phase, non-pivotal, and most device studies outside those specific submission pathways fall outside the statutory requirement as written.
Current status of FDA’s implementing guidance — read this section carefully
This is the part of the requirement that has genuinely moved, and any source that states it flatly as settled is oversimplifying. The timeline, as corroborated across multiple law-firm client alerts and health-policy trackers:
- April 2022: FDA published an initial draft guidance on Diversity Plans, ahead of FDORA’s enactment.
- June 2024: FDA issued a revised draft guidance, “Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies,” replacing the 2022 draft and reflecting the enacted statutory language.
- September 26, 2024: the public comment period on the 2024 draft closed, after more than 150 comments were submitted; stakeholder comments reportedly showed real disagreement over the guidance’s scope and questioned how enforceable it would be in practice.
- January 2025: the draft guidance was removed from FDA’s website without a public notice or explanation, reported at the time as connected to a federal executive order affecting diversity-, equity-, and inclusion-related agency guidance.
- February 11, 2025: per multiple secondary reports of a court order, HHS/FDA restored the draft guidance to its Diversity Action Plan guidance webpage.
- June 2025: the statutory deadline for FDA to issue a final guidance — nine months after the 2024 comment period closed — passed. Based on the sources available at the time of writing, that deadline does not appear to have been met with a published final guidance; the document remains, as far as can be independently confirmed, in draft form, explicitly marked non-binding.
What this means in practice: the statutory requirement itself — FDCA 505(z)/520(g)(9) — is real, current law, not proposed legislation. What remains unsettled is the FDA’s own operational guidance on how sponsors should satisfy it, which has been withdrawn, restored, and, per the sources reviewed, still not finalized past its own statutory deadline. Sponsors and research administrators should treat the guidance’s content as the best available roadmap for what FDA will expect, while watching for a final version that could adjust specifics. This section should be treated as REPORTED-tier, sourced from law-firm client alerts and health-policy reporting rather than a live FDA.gov page, and is worth rechecking against FDA’s current guidance index before relying on it for a specific submission.
Effective date and enforcement
Under the framework described in the 2024 draft guidance, once a final guidance is published, sponsors get 180 days to come into compliance, and the requirement applies only to covered studies “for which enrollment begins after” that 180-day date — it is not retroactive to trials already enrolling. Because no final guidance has been confirmed published, an exact enforceable date cannot currently be stated with confidence; it is a function of whenever finalization actually happens.
On paper, the consequence of not submitting a required Diversity Action Plan is real: failure to do so is treated as a prohibited act under FDCA Sections 301(d) and 301(q)(1), which can carry civil or criminal penalties under the Act’s general enforcement provisions. In practice, the draft guidance itself does not spell out a specific enforcement mechanism or penalty schedule for Diversity Action Plan non-compliance specifically, and commentary from the period suggests FDA’s near-term posture is oriented toward encouraging compliance and engaging with sponsors during review, rather than punitive enforcement, at least while the guidance remains unfinalized.
What this means for research administrators and sponsors now
Even with the guidance’s final status unsettled, the statutory requirement doesn’t disappear, and several practical steps hold up regardless of how finalization plays out:
- Identify covered studies early. If a program includes a Phase 3 or pivotal drug/biologic study, or a device study headed for an IDE, 510(k), De Novo, or PMA submission, plan for a Diversity Action Plan as part of the submission package rather than as an afterthought late in trial design.
- Build enrollment goals from real epidemiological data. The rationale requirement means goals can’t just be round numbers — they need to be traceable to the actual demographic distribution of the condition under study, which is also the same evidence base that supports a defensible patient recruitment strategy.
- Coordinate the Diversity Action Plan with the broader recruitment and site-selection plan. Enrollment goals that assume specific demographic reach are only credible if the sites, recruitment channels, and community-engagement plan behind them can actually deliver that reach — this is an operational document, not just a regulatory-affairs filing exercise.
- Track the guidance’s finalization status directly. Specifics such as the exact effective date, any changes to required content, and enforcement posture could shift once, and if, a final version is published. Sponsor legal and regulatory-affairs counsel monitoring FDA’s guidance index is the most reliable way to stay current given how much this requirement’s history has already moved.
Frequently asked questions
What is a Diversity Action Plan?
A Diversity Action Plan is a document a clinical trial sponsor submits to FDA, required by FDORA for certain drug, biologic, and device studies, setting out enrollment goals for the study population disaggregated by age group, sex, race, and ethnicity, the rationale behind those goals, and the sponsor’s plan for meeting them.
Which clinical trials require a Diversity Action Plan?
Phase 3 or other pivotal studies of drugs and biological products, and device clinical studies submitted as part of an IDE application, 510(k) premarket notification, De Novo request, or PMA application. Earlier-phase and non-pivotal studies generally fall outside the statutory requirement.
Is the FDA Diversity Action Plan requirement currently in effect?
The underlying statutory requirement (FDCA 505(z)/520(g)(9), enacted via FDORA in 2022) is current law. FDA’s implementing guidance, however, has been through a genuinely unsettled period — issued in draft in 2024, removed from FDA’s website in early 2025, restored per a reported court order in February 2025, and, per the most recent sources reviewed, still not confirmed as finalized past its own statutory June 2025 deadline. Sponsors should verify the guidance’s current status directly with FDA or regulatory counsel before finalizing a submission.
What happens if a sponsor doesn’t submit a required Diversity Action Plan?
Failure to submit a required plan is treated as a prohibited act under FDCA Sections 301(d) and 301(q)(1), which can carry civil or criminal penalties under the Act’s general enforcement framework. The draft guidance does not lay out a specific penalty schedule for this requirement, and near-term FDA posture has leaned toward engagement over punitive enforcement while the guidance remains in draft.
How is a Diversity Action Plan different from a general clinical trial recruitment plan?
A Diversity Action Plan is the demographic-enrollment-goals document FDA requires as part of the regulatory submission for a covered pivotal study. A recruitment plan is the broader operational strategy — sites, channels, screening, retention — for enrolling a trial generally. In practice the two need to be built together: the Diversity Action Plan’s goals are only credible if the recruitment plan can actually deliver the demographic reach it promises. See CASRAI’s guide on clinical trial patient recruitment for the operational side.
