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- CAP discusses improved device transparency with FDA
The CAP met with FDA Commissioner Martin Makary, MD, and other FDA officials on August 26 to discuss pathologists’ concerns and explore future opportunities for collaboration.
The impact: The CAP will follow up on several priority issues ranging from supply chain challenges to advancements in AI-enabled devices.
Representing the CAP were President Donald Karcher, MD, FCAP; President-Elect Qihui "Jim" Zhai, MD, FCAP; Council on Government and Professional Affairs Chair Joe Saad, MD, CPE, FCAP; and Value-based Programs and Healthcare Policy Committee Chair Gregary Bocsi, DO, FCAP.
FDA Meeting Readout
The meeting began with officials thanking the CAP for its contributions to improve laboratory data infrastructure through the FDA SHIELD project.
CAP leaders then spoke to a reliance on the FDA's timely, evidence-based reviews to ensure patient safety. We emphasized the need for clinicians to have access to the right test for patients.
AI-enabled devices: Transparency of information regarding AI development is also crucial for pathologists to verify device use in the laboratory setting.
- The data used to test and train the device should come from a pool of diverse laboratory settings to ensure applicability to the US population.
- The CAP and FDA agreed on the importance of education on the intended use and specifications involved in the FDA's clearance process.
One final item: Obtaining certain lab supplies and materials still remains a problem for pathologists and their laboratories.
- The FDA officials expressed an interest in collaborating with the CAP to obtain more dynamic information on these challenges.