Somebody at Limbic sat down and wrote out every kind of patient who should never be handed their product. The list runs long. Suicidal or homicidal ideation. Moderate to severe dementia. Any psychiatric disorder with psychotic features. Eating disorders of any severity. Pregnancy. Patients 81 or older with a frailty indication. People who don't have a telephone. That list now sits on an FDA webpage, and it's doing a job the FDA isn't doing.
Enforcement discretion is not approval
Limbic is one of four companies in the FDA's TEMPO pilot. The agency updated the participant table on August 21. TEMPO stands for Technology-Enabled Meaningful Patient Outcomes, and it runs on enforcement discretion. The FDA isn't approving anything here. It's saying it doesn't intend to enforce certain requirements, premarket authorization among them, when a device is offered inside a Medicare payment model called ACCESS that pays for chronic care. The agency prints the caveat on the same page: the effectiveness of these devices, for the uses they're participating under, has not been evaluated.
The other three participants are SonderMind, with an app that runs alongside therapy for depression and anxiety; Cadence Solutions, with HypertensionOS, which supports clinician-supervised initiation and titration of blood pressure medication; and Dexcom, with a glucose health program. Each row of the table carries a manufacturer, a device name, a clinical use area, an intended use, and contraindications. Limbic's contraindications run most of a paragraph. SonderMind's name four conditions. Cadence and Dexcom both read N/A.
The sentence you wrote is the whole boundary
Nobody at the agency weighed those entries against a body of evidence and decided they were right. Each company wrote its own, and the FDA published it. Under a normal clearance, the indication statement is the settlement of an argument you can point at afterward. Here it's an assertion. So the sentence a company wrote about who its product is for is the only line anyone can hold it to.
I've been on the writing end of that sentence. At Galen Robotics we first framed the device as a remote-control telemanipulator, which parked us next to da Vinci and failed. We reframed it as a stabilizer that improves a surgeon's access to anatomy at the end of a long instrument. Same machine, different sentence. The second one cleared as a de novo, and it cleared because the framing changed what evidence we owed. Claim your device makes surgery safer for the patient and you've invited a clinical trial. Claim it improves access and you've invited engineering and usability work, which is cheaper, faster, and yours to control.
Read the TEMPO table as the FDA getting easier and you'll take the wrong lesson from it. The bar sits where it always sat. What changed is when you meet it. Under premarket review you learn what the agency thinks of your framing before a patient touches the product. Under enforcement discretion you learn later, from real-world data you collected inside boundaries you drew yourself.
There is a later, and it arrives with your own data
The FDA expects TEMPO participants to file a 510(k) or another marketing submission eventually, built on the data gathered during the pilot. That data can only ever answer the question the indication asked. Draw the indication too wide and you'll spend two years collecting evidence that supports no claim you can defend. Draw it too narrow and you end up with a cleared product nobody wants to pay for. The agency also asks participants for a proposed indications-for-use statement in the very first email they send, before any of the safety data. That ordering is the tell. Framing comes first because everything downstream is measured against it.
I'd hold the enforcement-discretion posture loosely too. A regulatory attorney once told me that FDA agreement in a pre-submission doesn't obligate the review team that reads your file later, and I watched it happen. Galen had a study design the agency signed off on in the Q-sub, with resident surgeons performing the procedures. Substantive review came back wanting attendings. We re-ran a 16-subject cadaver study in two weeks because the neurosurgery department at Johns Hopkins handed us a free OR and cadaver heads. That kind of rescue isn't reproducible, and it taught me that a favorable posture from the agency today is exactly that. A posture.
None of this is confined to digital health. Any time a regulator or a big customer hands you a lighter way in, whether that's an other-transaction agreement at DoD, a sandbox, or a pilot purchase order that skips the usual qualification, the definition work you skipped doesn't evaporate. It lands on you, and it stays there.
Dave's take
I'd take the pilot. Reaching patients while you build the evidence is worth a great deal, and the four companies in it clearly agree. What I'd fight about before anyone signs is the wording of that intended-use column, because it's the one decision in the whole arrangement nobody else will make for you and nobody else will catch.
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Dave Saunders is the founder of Base Reality Group and a Fractional CPO for product companies. He was a founder and operator at Galen Robotics, where the surgical-robotics platform earned FDA De Novo authorization in 2023, and he managed a 35-patent portfolio licensed from Johns Hopkins. He wrote Founders Who Finish and publishes The Build. More about Dave →