Is Burna AI a medical device?

Burna AI is designed as non-device clinical decision support. Every grade is a draft until a clinician signs it, and the CTCAE criterion and the source line sit on screen so the clinician can check the basis independently, one of the conditions section 520(o)(1)(E) of the Federal Food, Drug, and Cosmetic Act sets for software functions outside the device definition. Burna AI has submitted a Q-Submission to FDA, and its application to the CDER Emerging Drug Safety Technology Program (EDSTP) is in progress. The platform grades, attributes, codes and reports adverse events for clinical research. It does not prescribe, recommend a dose or alter a care plan. AI suggests, clinicians decide.