Congress ordered a guidance, not a rule

FDA finalized new guidance on real-world evidence for medical devices in December 2025, replacing a version that had stood since 2017. The timing was not FDA’s to choose. A provision inside a 2022 appropriations act ordered the guidance to be revisited, on a schedule Congress set — and even with a statute behind it, what came out the other end is still guidance, not a rule.

A deadline, not a standard

Section 3629 of the Food and Drug Omnibus Reform Act of 2022 — enacted December 29, 2022 as part of the Consolidated Appropriations Act, 2023, Public Law 117-328 — directs FDA to issue or revise guidance on the use of real-world data and real-world evidence in its regulatory decisions. FDA had already published device-specific guidance on the subject in 2017; Section 3629 did not touch that guidance’s content, and it did not write a new evidentiary standard into the statute itself. It ordered a document revisited, not a bar met.

Two obligations, one document

FDA opened the revision with a December 2023 draft, which its own Federal Register notice ties directly to satisfying Section 3629(a)(2). The final guidance, published December 18, 2025, closes a second obligation at the same time: a commitment FDA made separately, in Section V.F. of its negotiated MDUFA V performance goals. A statutory deadline and a user-fee-negotiated commitment, made years apart to different audiences, converged on the same rewrite — which is why this revision arrived on a schedule FDA did not fully control, unlike the eight quiet years between the original guidance and this one.

Congress can order a guidance document into existence and set the date it arrives. It cannot, in the same statute, make that document bind anyone — those are different legal acts, and only one of them happened here.

Still not a rule

21 CFR 10.115, FDA’s own good-guidance-practices regulation, is what actually governs the document Section 3629 forced into being: a guidance does not bind FDA or the public the way a regulation does, states FDA’s current thinking rather than a fixed requirement, and leaves a sponsor free to propose a different approach if it satisfies the underlying statute or regulation another way. Nothing in Section 3629 changes that status. Congress compelled FDA to write down, again, what real-world evidence it currently considers reliable enough to support a device decision — it did not convert that answer into a codified requirement a sponsor could hold FDA to, and a future FDA can revise the same guidance again without asking Congress first.

The practice

A real-world-evidence program built toward a future submission is being built against a non-binding recommendation that has already been rewritten twice in eight years, most recently on a deadline set by statute rather than by scientific consensus. That is worth knowing before treating any specific paragraph of the current guidance as fixed — reading what changed across the 2017, 2023, and 2025 versions, and reading it again the next time FDA revises it, is work for a regulatory professional against the current document, not a conclusion this post reaches for a specific submission. This is regulatory intelligence and method, never regulatory advice about what evidence a specific device needs.