US FDA requirements for medical devices: 510(k) premarket notification, classification, 21 CFR Part 820 and establishment registration explained.
FDA denied a 510(k) exemption for radiology CAD and CADt software, proposed eSTAR for PMAs and opened a robotics draft guidance. Three actions, two comment deadlines in November.
What a US FDA 510(k) actually requires in 2026 – predicate selection, eSTAR, timelines, FY2026 fees, US Agent obligations and the new QMSR – explained by regulatory consultants who file them.
