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- CAP Urges FDA to Ensure Post-Market Surveillance Burdens Don’t Fall to Pathologists for AI Software
While the CAP is in support of draft guidance concerning market submission of artificial intelligence and machine learning medical software, the CAP urged the US Food and Drug Administration to take the necessary steps to ensure regulatory burden is not transferred to pathologists that are required to provide local verification of enabled device software functions.
The FDA published its regulatory approach tailored to artificial intelligence/machine learning (AI/ML)-enabled devices to increase patients’ access to safe and effective AI/ML-enabled devices in April. The guidance proposes recommendations on what information manufacturers should include in an FDA marketing submission so that they can alter their AI/ML software over time without needing to fill out another FDA marketing submission. The CAP analyzed the draft guidance and provided the FDA with feedback on June 30. Because of the expected impact of these technologies on the practice of pathology and laboratory medicine, and the need to adhere to CLIA in the laboratory setting, the CAP has a keen interest in the regulatory approach for AI/ML technologies.
In the June 30 letter, the CAP supported the concepts proposed within the current draft guidance however, for clinical laboratories to meet CLIA requirements, it is imperative that performance monitoring or regulatory responsibilities do not place undue burden on pathologists or other physicians.