Clinical Decision Support Software Guidance for Industry and Food and Drug Administration Staff

The Combination Products Coalition (CPC), representing drug, biological, and medical device manufacturers, supports the FDA's guidance but proposes specific revisions to clarify regulatory boundaries. They argue for clearer exemptions for patient-facing software, more flexible interpretations of "clinically appropriate" and "time-critical" criteria, and the inclusion of AI/ML-specific validation methods to reduce regulatory burden and promote innovation.

MEDITECH, a medical information technology company, opposes the proposed guidance because it classifies foundational EHR functions as regulated medical devices. They argue that this creates an excessive regulatory burden that could lead to alert fatigue, increase documentation requirements, and hinder the operational efficiency of healthcare delivery.