FDA clinical decision support and wellness device guidance (January 2026)
Published September 18, 2026
What changed
Fact. Named instrument, date, jurisdiction. Cited.
In January 2026, the U.S. Food and Drug Administration issued updated Clinical Decision Support Software guidance (FDA-2017-D-6569) and updated General Wellness: Policy for Low Risk Devices (issued January 6, 2026, superseding the 2019 version). Both are FDA guidance, not statutes.
The CDS guidance clarifies which clinical decision support software functions are excluded from the device definition under section 520(o)(1)(E) of the FD&C Act (Non-Device CDS criteria). It also states that FDA's existing digital health policies continue to apply to software functions that meet the definition of a device, including those intended for use by patients or caregivers.
Why it matters for veterans
Stakes in plain language. If we interpret, we say so.
Veterans' care often involves software sitting between the veteran and a clinician. FDA treats software that recommends care to a patient as higher-risk than software that only supports a clinician's decision. The stake is who is deciding care, and whether the veteran knows which side of that line an app is on.
LastVet's position
The stance.
When the FDA updated its guidance in January 2026, it kept a clear line between software that supports a clinician's decision and software that recommends care directly to a patient. The second is treated as higher-risk, and rightly so.
LastVet's position is that Meridian belongs on the right side of that line by design, because Meridian is not in the business of suggesting care. It is in the business of coordinating it. Meridian organizes a veteran's consented record, explains that record back in cited plain language, and is built to connect the veteran to providers. It does not diagnose, it does not treat, and it does not tell a veteran what care they need. That judgment belongs to a clinician, and we keep it there on purpose.
This is not a constraint we work around. It is the design. A veteran's care decisions should be made by the people trained to make them, with the veteran in the room. LastVet's job is to make sure the right information and the right connections reach that room, not to substitute for it.
What we're doing
Dated actions only.
- 2026-08-18. A clinical advisor of record reviewed the crisis-protocol content. That review is clinical-content endorsement. It is not validation of the deployed system.
- 2026-09-16. The full crisis handoff was built and briefly enabled, then rolled back the same evening. Current shipped state: 988 stub. Copy in-app: "Crisis handoff is not live in this build yet." Full protocol remains behind a flag set to false, pending that advisor's pre-go-live validation checklist.
- 2026-09-18. Meridian stays not live. The code gate is closed.
m1_eligibleis held. Neither the explainer nor the matcher is serving veterans.