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 traini

For medical device manufacturers, these internationally developed technical documents (like ISO 14971 for Risk Management, ISO 10993 for Biocompatibility etc.) are more than just guidelines—they are a very efficient path to market. By declaring conformity to these standards, medical device manufacturers provide the FDA with a proven "blueprint" for device’s safety and performance, significantly streamlining the premarket review process. For example, if a medical device manufa