Close clinical evidence gaps

Clinical gaps can be factual, methodological, or judgment-based. A missing report is a factual gap; an unsupported claim is an evidence gap; an uncertain equivalence rationale may require expert judgment.

Answer clinical gap requests with the most direct evidence available. If evidence does not exist, explain what is missing and whether the gap will be addressed through PMCF, claim limitation, additional testing, or another controlled action.

Do not force a positive conclusion before the evidence supports it. A cautious, transparent clinical evaluation is more defensible than a confident but unsupported report.