The law reached devices. The guidance hasn't.

A Diversity Action Plan reads, to a device sponsor who has only ever watched the requirement apply to drug trials, like someone else’s paperwork. The 2022 statute that created it did not stop at drugs. It reached into the device section of the FD&C Act on the same page, and the guidance that is supposed to tell a sponsor exactly what the plan has to contain is, right now, still a draft — past the date the statute itself set for finishing it.

Where the device half of the mandate actually sits

The Food and Drug Omnibus Reform Act of 2022, Section 3601, added the Diversity Action Plan requirement twice — once to Section 505(z) of the FD&C Act for drugs, and separately to Section 520(g) for devices. The device trigger is not tied to risk class or study phase. It is tied to the submission: a study that needs an investigational device exemption files its plan with the IDE; a study that doesn’t need one — most 510(k) and De Novo studies — files its plan with the eventual premarket notification, classification request, or PMA, unless the study is itself exempt from IDE requirements under 21 CFR 812.2(c). Every plan states the same three things: enrollment goals broken out by age group, sex, race, and ethnicity for the population the device is meant to treat, the sponsor’s rationale for those goals, and how the sponsor intends to reach them.

The clock the statute wrote

FDORA did not make the requirement effective on enactment. It tied the mandate to a guidance FDA had not yet written: the statute set a schedule for a draft, then required final guidance within nine months of the draft’s comment period closing, and the submission requirement itself only reaches a clinical study whose enrollment commences 180 days after that final guidance publishes. Nothing about a device sponsor’s obligation turns on the year FDORA passed. It turns on a document FDA has to finish first.

A mandate that activates on publication is not yet a mandate for any study enrolling today — it is a mandate waiting on FDA to publish the thing that starts it.

The document the clock is waiting on

FDA issued the current draft — Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies, docket FDA-2021-D-0789 — on June 28, 2024, with comments due that September. Nine months past that closing date, by the statute’s own schedule, lands around the end of June 2025. No final guidance has published. The draft is still the only version on FDA’s site, still marked non-binding, well past the deadline the statute itself set for replacing it.

The practice

None of this excuses a device sponsor from reading Section 520(g) — the requirement is law, and it names devices by submission type, not by analogy to drugs. What it does mean is that no device study’s enrollment date has yet crossed the 180-day line the statute actually draws, because the final guidance that draws it hasn’t published. A sponsor planning a pivotal device trial now is building against a draft that describes FDA’s expected practice without yet being able to enforce it on a fixed date. The guidance’s eventual finalization would post as a Federal Register notice — one of the sources this product does ingest, listed on what we monitor and what we deliberately don’t — so the moment that clock actually starts is a moment this product is built to catch. Whether a specific trial’s design should anticipate the draft’s content before the clock starts is a judgment for the sponsor’s own regulatory and clinical team; this describes where the statutory requirement stands today, never advice on a given study’s enrollment plan.