> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# FDORA Requires Trial Diversity Action Plans: Attorneys
- URL: https://www.fdaweb.com/fdora-requires-trial-diversity-action-plans-attorneys/
- Published: 2023-01-26T12:00:00.000Z
- Updated: 2026-09-14T18:13:28.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5153627

A section of the Food and Drug Omnibus Reform Act (FDORA), which was passed by Congress at the end of 2022, requires sponsors of most drug and medical device clinical studies to submit a diversity action plan when they submit key trial documents to the agency. The requirement will apply to clinical trials that start enrollment 180 days after FDA finalizes guidance on the topic.

Attorneys **Faraz Siddiqui** and **Deborah Livornese** (Hyman, Phelps & McNamara) write in their firm’s *FDA Law Blog* that the legislation is the latest in a series of agency initiatives to encourage diversity in clinical trials.

One relevant FDORA subsection requires sponsors of any Phase 3 or other pivotal drug studies, other than bioavailability or bioequivalence studies, to submit diversity action plans by the time they submit the study protocol. Another subsection similarly requires medical device sponsors to submit diversity action plans.

The law specifically exempts submissions made under the expanded access provisions of the Federal Food, Drug, and Cosmetic Act from having to submit diversity plans. The requirements also do not apply to a discrete set of device studies, the attorneys say, such as pre-amendment devices, cleared devices used on-label, certain diagnostic devices, custom devices, veterinary use devices, devices for research with laboratory animals, and certain devices undergoing consumer preference testing or modification testing.

FDA is permitted to waive the requirement on its own initiative or at the request of a sponsor. However, to grant a waiver, the agency must determine that the prevalence or incidence of the disease or condition being studied makes it impractical to conduct a clinical trial under a diversity action plan, or that a waiver is necessary to protect public health during a public health emergency.

The law requires FDA to issue or update guidance on the format and content of diversity action plans by the end of 2023\. The attorneys say the law contains a lot of details about what should be in the guidance and thus in an action plan.

Diversity action plans should contain **(1)** the sponsor’s goals for clinical study enrollment, disaggregated by age group, sex, and racial and ethnic characteristics; **(2)** the rationale for the enrollment goals, including information about the disease or condition and its prevalence or incidence among various demographics; and **(3)** how the sponsors intend to meet such goals, including demographic-specific outreach and enrollment strategies, inclusion and exclusion practices, and diversity training for study personnel.

FDORA requires the agency to convene public workshops and solicit comments on increasing the enrollment of historically under-represented populations in clinical studies and encouraging clinical study diversity, and then publish a report on the workshops’ recommendations. FDA also must submit an annual report to Congress summarizing its aggregated experience with sponsors’ diversity action plans, beginning no later than early 2025.