The FDA denied a petition from Harrison.ai seeking a partial exemption from premarket review for certain diagnostic/detection AI devices, preserving the existing regulatory status quo. The agency’s decision relies on whether the device has 510(k) clearance in a comparable category and whether the manufacturer maintains a robust postmarket plan. For developers, the ruling signals that risk controls and evidence expectations for AI-enabled diagnostics will remain embedded in premarket processes unless broader exemptions are justified through new regulatory pathways.