Diversity Action Plans (DAP)
Section 3604 of the Food and Drug Omnibus Reform Act (FDORA) of 2022 requires FDA to submit to Congress, and publish on the Agency’s website, an annual report that summarizes in the aggregate the Diversity Action Plans received and whether, for drugs, biological products, and devices, FDA approved, licensed, cleared or classified, the clinical studies conducted with respect to such applications, met the demographic enrollment goals from the submitted Diversity Action Plans. On this page you will find all Diversity Action Plans Summary Reports for FDA.
Refer product specific questions regarding Diversity Action Plans to the respective review division. Nonproduct specific questions on Diversity Action Plans can be referred to DiversityActionPlanQuestions@fda.hhs.gov.
Annual DAP Summary Reports
The following annual summary reports are available from the Center for Drug Evaluation and Research (CDER), the Center for Biologics Evaluation and Research (CBER), and the Center for Devices and Radiological Health (CDRH).
Additional Information and Resources
The following frequently asked questions are provided for reference. We encourage you to review Draft Guidance for Industry: Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies (June 2024) or the DAP draft guidance.
Refer Diversity Action Plan questions related to a specific drug or device development program to the applicable review division as follows:
- For CDER, refer product specific questions to CDER Offices and Divisions
- For CBER, please contact the Regulatory Project Manager assigned to the Investigational New Drug (IND) application or email Industry.Biologics@fda.hhs.gov
- For CDRH, refer product specific questions to Office of Product Evaluation and Quality
- For the Oncology Center of Excellence (OCE), refer product specific questions to the Regulatory Project Manager assigned to the Investigational New Drug (IND) or marketing application
Refer nonproduct specific questions on Diversity Action Plans to DiversityActionPlanQuestions@fda.hhs.gov.
On December 29, 2022, the Consolidated Appropriations Act, 2023, which included the Food and Drug Omnibus Reform Act of 2022 (FDORA), was enacted.1 FDORA amends the Federal Food, Drug, and Cosmetic Act (FD&C Act) to require submission of a “Diversity Action Plan” for:
- A clinical investigation of a new drug that is a phase 3 study (as defined in 21 CFR 312.21), or as appropriate, another pivotal clinical study of a drug (other than a bioavailability or bioequivalence study);
- A device for which submission of an application for an investigational device exemption (IDE) is required;
- A device for which submission of an application for an IDE is not required (except for a device being studied under 21 CFR 812.2(c)) and where a premarket notification under section 510(k), request for classification under section 513(f)(2), or application for premarket approval under section 515 is submitted.
A Diversity Action Plan must include:
- The sponsor’s goals for enrollment in the clinical study, disaggregated by race, ethnicity, sex, and age group of clinically relevant study populations;
- The sponsor’s rationale for such goals; and
- An explanation of how the sponsor intends to meet such goals
Per section 3602(c) of FDORA, the requirements for Diversity Action Plans apply to clinical studies for which enrollment commences after 180 days from the publication of the final guidance.
While the requirement to submit Diversity Action Plans has not commenced, many sponsors have initiated the process of preparing and submitting diversity plans.
Diversity Action Plans are intended to increase enrollment in clinical studies of participants who are members of historically underrepresented populations to help improve the strength and generalizability of the evidence for the intended use population.
For drugs,2 a Diversity Action Plan is required for a clinical investigation of a new drug that is a phase 3 study (as defined in 21 CFR 312.21), or as appropriate, another pivotal clinical study of a drug (other than a bioavailability or bioequivalence study).3
For devices, a Diversity Action Plan must be included in the Investigational Device Exemption (IDE) application for clinical studies of the device. An IDE application is required to be submitted to FDA if the sponsor intends to use a significant risk (SR) device (as defined in 21 CFR 812.3(m)) in an investigation, intends to conduct an investigation that involves an exception from informed consent under 21 CFR 50.24, or if FDA notifies the sponsor that an application is required for an investigation.4
In addition, for devices for which an IDE application to FDA is not required, except for a device being studied as described in 21 CFR 812.2(c), sponsors must develop a Diversity Action Plan for the related device clinical study. Diversity Action Plans for these devices must be submitted to FDA in any premarket notification,5 request for classification,6 or application for premarket approval7 under section 510(k), 513(f)(2), or 515 of the FD&C Act, respectively.
Per section 3602(c) of FDORA, the requirements for Diversity Action plans apply to clinical studies for which enrollment commences after 180 days from the publication of the final guidance.
Generally, sponsors are encouraged to discuss the Diversity Action Plan with FDA as soon as practicable during medical product development. Sponsors must submit Diversity Action Plans for certain clinical studies for drugs and devices according to the following statutorily required timelines:
- For drugs, sponsors must submit the required Diversity Action Plan to the relevant IND application as soon as practicable but no later than the date on which the sponsor submits the protocol to FDA for the phase 3 study or, as appropriate, other pivotal study. Because FDA’s review of and feedback on the Diversity Action Plan is most efficient if it occurs in the context of discussions regarding trial design, study population selection, and other aspects of the clinical study, FDA recommends submission of the Diversity Action Plan when a sponsor is seeking feedback regarding the applicable clinical study for the drug (typically at the End-Of-Phase 2 meeting).
- For device clinical studies that require an IDE application to be submitted to FDA, the Diversity Action Plan must be included in the IDE application. Sponsors of certain studies for which submission of an IDE application is not required to be submitted must develop a Diversity Action Plan to guide the development of any clinical study with respect to that device and must submit the Diversity Action Plan as part of the device’s premarket notification 510(k), PMA application, or De Novo classification request.8
The Diversity Action Plans required under section 505(z) and section 520(g)(9) of the Federal Food, Drug, and Cosmetic Act as amended by section 3601 of the Food and Drug Administration Omnibus Reform Act of 2022 (FDORA), apply to clinical investigations for which enrollment commences after 180 days from the publication of FDA’s final guidance outlining the format and content of those Diversity Action Plans (see section 3602(c) of FDORA). The guidance published in June 2024, was a draft guidance and has not been finalized. As such, waiver requests will not be considered at this time. However, diversity and equity in clinical research is a priority for the Agency, and FDA encourages sponsors to discuss with review divisions ongoing efforts to enroll a diverse patient population relevant to their proposed indication.
Although Diversity Action Plans are not required for all clinical studies,9 FDA strongly recommends that sponsors develop and implement a comprehensive diversity strategy across the entire clinical development program, including in early studies, when possible.
The draft guidance suggests that when developing Diversity Action Plans, the sponsor should consider how individual clinical studies may fit into an overall clinical development program for the medical product (i.e., for a particular indication or intended use), and how such individual studies should help generate data representing the clinically relevant population’s demographic characteristics consistent with the incidence or prevalence in the disease population for the program. In such a situation, the draft guidance suggests that the Diversity Action Plan for each clinical study should reflect a strategy that leads to an overall proportionate representation, even though individual clinical studies may not have such representation.
- 1Public Law 117-328.
- 2Use of term “drug” refers to both human drugs approved under section 505 of the FD&C Act (21 U.S.C. 355) and biological products licensed under section 351 of the Public Health Service Act (PHS Act) (42 U.S.C. 262) that are regulated as drugs.
- 3See Section 505(z)(1) of the FD&C Act.
- 421 CFR 812.20(a).
- 5See 21 CFR 807.81.
- 6See section 513(f)(2) of the FD&C Act.
- 7See 21 CFR 814.20.
- 8A study that is exempt from the requirements of the IDE regulations under 21 CFR 812.2(c) does not require the development or submission to FDA of a Diversity Action Plan under section 520(g)(9)(A)(ii) of the FD&C Act.
- 9See section 505(z) of the FD&C Act for drugs and section 520(g)(9) of the FD&C Act for devices for the specific circumstances for which a Diversity Action Plan is not required.