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Regulatory positioning

This page explains, in plain terms, how Oriva is designed to fit within U.S. rules for clinical decision support software.

In short. Oriva is designed to operate as Non-Device Clinical Decision Support (CDS). It provides information for a licensed clinician to review and independently evaluate. It does not diagnose, and it is not intended to be a medical device.

Non-Device CDS

Under the 21st Century Cures Act and FDA guidance, certain clinical decision support software is excluded from being regulated as a medical device when it meets specific criteria, including that it supports, rather than replaces, a clinician's judgment, and that the clinician can independently review the basis for its recommendations.

Oriva is built with those criteria in mind: it surfaces a likely picture and the supporting detail, displays its reasoning, and is intended for clinician review before any care decision.

What this means in practice

Oriva produces pre-visit triage information, not a diagnosis or treatment plan.
A licensed provider reviews the output and makes the clinical decision.
The engine is deterministic and auditable, so its reasoning can be examined.

Honest caveats

Oriva is not FDA-cleared or FDA-approved, and this page is not a regulatory determination. Whether software qualifies as Non-Device CDS depends on its specific design and use, and the rules can change. We work with regulatory counsel on our positioning, and we recommend your organization evaluate its own obligations.

Questions

For regulatory questions, email hello@oriva.health.