FDA Issues Warning Letter Over Unapproved AI/ML Changes
In the September 1, 2026, Warning Letter to O.N. Diagnostics, LLC, the FDA cited the company for marketing an adulterated and misbranded medical device following an unapproved AI/ML update. Such an update should require a new regulatory submission.
Key violations highlighted by the FDA include:
1. Unapproved AI/ML Updates: Releasing a new machine learning model for vertebral landmarking without a 510(k) submission. The FDA emphasized that changing model architecture or training data alters performance and failure modes, mandating full V&V and prior regulatory clearance.
2. Cybersecurity Exposure: Migrating from a desktop application to a web-based architecture without addressing the expanded cyberattack surface area and additional vulnerabilities.
3. Unvalidated Codebase Migration: Failing to re-verify and re-validate the entire codebase—including third-party software components—following platform changes.
An FDA Warning Letter is a public, formal notice of non-compliance. Companies have 15 working days to respond with a detailed plan for corrective and preventive actions.
Comments