Who makes the final call on a grade, Burna AI or the clinician?

The clinician. AI suggests, clinicians decide: human-in-the-loop, always. Burna AI drafts the grade, the per-drug attribution and the MedDRA code, each with the CTCAE criterion and the line in the medical record behind it. A grade becomes a record only when a qualified investigator signs it, and the 21 CFR Part 11 signature records what was accepted, what was overridden and the citation set as signed. Because the clinician can independently review the basis for every suggestion, Burna AI is built as non-device clinical decision support. 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 engine equips investigator judgment and helps elucidate the safety profile.