CurebaseDemo
    New ArticleRead Article →
    Back to Resources

    FDA Diversity Action Plan: 2026 Guide and Compliance

    fda diversity action plan

    Clinical trials are the backbone of medical advancement, but for decades, they haven’t accurately reflected the diverse world we live in. To address this long-standing issue, the U.S. Food and Drug Administration (FDA) is implementing a major policy change with the FDA Diversity Action Plan. An FDA Diversity Action Plan (DAP) is a formal document that clinical trial sponsors must create to outline their strategy for recruiting and retaining a diverse group of participants. This new requirement aims to close critical gaps in our understanding of how new treatments work for different people, noting that Black patients, for example, made up only 3% of participants in global oncology trials between 2013 and 2022.

    This guide breaks down everything sponsors need to know about this new requirement, from the legal specifics to the practical steps for creating and submitting a successful plan.

    What Exactly Is an FDA Diversity Action Plan?

    The FDA Diversity Action Plan (DAP) goes beyond a simple suggestion; it’s a concrete roadmap. The formal document must specify enrollment goals for underrepresented groups, provide a scientific reason for those targets, and detail the specific actions the sponsor will take to achieve them. The ultimate purpose is to ensure that the people in a clinical trial more closely mirror the real-world patient population that will use the medical product once it’s approved.

    The Legal Foundation: FDORA and the FD&C Act

    The requirement for a diversity action plan isn’t just a new guideline, it’s written into law. The Food and Drug Omnibus Reform Act (FDORA), passed in December 2022, officially mandated these plans for many late-stage clinical trials. FDORA amended the federal Food, Drug, and Cosmetic (FD&C) Act, creating new sections that codify this requirement.

    For Drugs and Biologics: Section 505(z)

    This section of the FD&C Act applies the FDA Diversity Action Plan requirement to new drugs and biologics. It specifically targets Phase 3 trials and any other pivotal study intended to support a drug’s approval. This means late-stage drug development must now include formal, proactive planning for diverse enrollment.

    For Medical Devices: Section 520(g)(9)

    Similarly, Section 520(g)(9) extends the DAP requirement to the world of medical devices. This provision mandates a diversity plan for any device trial that requires an Investigational Device Exemption (IDE). Even for some device studies that don’t need an IDE, a plan must still be developed and submitted later with the marketing application.

    Which Clinical Trials Need a Diversity Action Plan?

    The mandate for an FDA Diversity Action Plan is focused on later-stage, confirmatory trials that provide the primary evidence for a product’s approval.

    This includes:

    • Phase 3 Clinical Studies: These are large-scale trials designed to confirm a treatment’s effectiveness and safety in hundreds or thousands of people before it can be approved.
    • Pivotal Clinical Studies: A pivotal study is any trial, regardless of its phase, that serves as the main evidence for FDA approval. This ensures sponsors can’t simply label a definitive trial as “Phase 2” to avoid the requirement.
    • Applicable Products: The rules apply to trials for new drugs, biologics, and medical devices, with only a few exceptions like bioavailability studies for generic drugs.

    Crafting Your Plan: The Three Core Components

    A successful FDA Diversity Action Plan is built on three key pillars: clear goals, a solid rationale, and a practical strategy.

    1. Setting Clear Enrollment Goals

    Sponsors must define specific targets for enrollment from various demographic groups. These goals need to be broken down, or disaggregated, by four key categories:

    • Race
    • Ethnicity
    • Sex
    • Age Group

    The FDA also encourages sponsors to consider other characteristics that can impact health outcomes, such as geographic location, socioeconomic status, and gender identity, though these are not statutorily required in the plan. These targets should be based on real data about the disease, not guesswork.

    2. Justifying Your Goals with a Scientific Rationale

    This section of the DAP explains why you chose your specific enrollment targets. You must provide a rationale grounded in scientific evidence. This includes citing data on the prevalence and incidence of the disease across different populations. If a condition disproportionately affects a certain group, your enrollment goals should reflect that, and your rationale must explain it. You should also discuss any known data that suggests a drug or device might have different effects based on demographic factors, like variations in drug metabolism.

    3. Outlining Your Strategy to Meet Those Goals

    This is the operational heart of your FDA Diversity Action Plan. It details the concrete steps you will take to find, enroll, and retain a diverse group of participants. For deeper tactics, see our guide to patient recruitment in clinical trials. Simply stating a goal isn’t enough; you have to show how you’ll get there.

    Common strategies include:

    • Community Engagement: Partnering with local clinics, patient advocacy groups, and community leaders to build trust and awareness.
    • Inclusive Site Selection: Choosing research sites in geographic areas with diverse populations.
    • Reducing Participant Burden: Offering practical support like transportation assistance, childcare, flexible scheduling, and at-home visits.
    • Accessible Communication: Providing study materials and eConsent forms in multiple languages and at appropriate reading levels.
    • Decentralized Clinical Trial (DCT) Methods: Using technology like telemedicine and remote monitoring to reach patients who live far from traditional research centers.

    Executing these strategies requires modern tools and operational expertise. An integrated EDC helps unify data capture and visibility across sites and remote workflows. Platforms that unify eClinical software with flexible community‑based site models, like the solutions offered by Curebase, are designed to solve these exact challenges by making trials accessible to any patient, anywhere.

    Navigating the Submission Process

    The timing for submitting your FDA Diversity Action Plan depends on the type of product you’re developing.

    Submission Timing for Drugs and Biologics

    For drug and biologic trials, the DAP must be submitted no later than when you submit the protocol for your Phase 3 or pivotal study. Sponsors are strongly encouraged to discuss their plan with the FDA much earlier, for instance during the End-of-Phase-2 meeting, to get feedback before the pivotal trial begins.

    Submission Timing for Medical Devices

    If your device study requires an IDE, the diversity plan must be included with the IDE application. If no IDE is needed, you still need to create a plan to guide the study, and you will submit it along with the final marketing application (e.g., a 510(k) or PMA). Device sponsors can also get early feedback from the FDA by using the Q-Submission program.

    Practical Considerations for Your DAP Submission

    How Long Should the Plan Be?

    The FDA wants these plans to be focused and practical. The draft guidance suggests a DAP should generally be no more than 10 pages long, excluding references. The goal is a clear, concise strategy document, not a novel.

    When Does This All Take Effect?

    The FDA Diversity Action Plan requirement will become effective 180 days after the agency publishes its final guidance on the topic. With the draft guidance released in June 2024, this means the rules will likely apply to most new pivotal trials that begin enrolling participants in late 2025 or beyond.

    Are There Exceptions? The Waiver Process

    The FDA can waive the DAP requirement in very specific situations, such as:

    • When a disease is extremely rare, making diverse enrollment impossible.
    • When implementing a plan is truly impracticable for other justifiable reasons.
    • During a declared public health emergency.

    Sponsors must formally request a waiver and provide a strong justification. The FDA will review these requests on a case-by-case basis.

    Transparency and Public Access

    The FDA is pushing for transparency. While the DAP itself is a regulatory submission, the agency “strongly encourages” sponsors to publicly share their enrollment goals and strategies in plain language on a public website, like ClinicalTrials.gov. This public accountability is a key part of the initiative.

    You can find the official draft guidance document on the FDA’s website or by searching for docket number FDA-2021-D-0789 on the federal Regulations.gov portal. While the public comment period on the draft guidance closed in September 2024, the submitted comments and the document itself remain available for public viewing.

    Putting Your Plan into Action

    Creating an FDA Diversity Action Plan is just the first step. The real challenge lies in executing it effectively. This requires a deep understanding of community engagement, patient-centric technology, and flexible operational models. Working with a partner that specializes in decentralized and hybrid trials can provide the infrastructure and expertise needed to turn your diversity goals into reality. To learn how an all-in-one platform can help you operationalize your next study, explore the solutions at Curebase.

    Frequently Asked Questions about the FDA Diversity Action Plan

    What is the main goal of an FDA Diversity Action Plan?

    The primary goal is to ensure that the demographic makeup of clinical trial participants (including race, ethnicity, age, and sex) reflects the actual patient population affected by the disease being studied.

    Is a Diversity Action Plan required for Phase 1 or 2 trials?

    Generally, no. The legal requirement applies specifically to Phase 3 and other pivotal trials for drugs, biologics, and devices. However, the FDA strongly encourages sponsors to consider diversity in earlier phases of development to set the stage for successful recruitment later on.

    What happens if we can’t meet our enrollment goals?

    The DAP is a plan, and sometimes plans need to be adjusted. The key is to include a strategy for monitoring enrollment progress and implementing corrective actions if recruitment is lagging in certain groups. Demonstrating a proactive, good-faith effort to meet the goals is crucial.

    Besides race and ethnicity, what other diversity factors are important?

    While the law mandates goals for race, ethnicity, sex, and age, the FDA also encourages considering other factors like geographic location (urban vs. rural), socioeconomic status, disability, gender identity, and sexual orientation to create a truly representative study population.

    How can technology help with my FDA Diversity Action Plan?

    Technology is a powerful enabler. Decentralized clinical trial (DCT) platforms, patient engagement apps, ePRO/eCOA, and telemedicine expand a trial’s geographic reach far beyond traditional sites, making it easier to connect with diverse and underserved communities. Modern eClinical solutions from companies like Curebase are built to operationalize these strategies and reduce participant burden.