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510(K) DEVICE MODIFICATION "UPDATES" UNDER DISCUSSION AT FDA

This article was originally published in The Gray Sheet

Executive Summary

510(K) DEVICE MODIFICATION "UPDATES" UNDER DISCUSSION AT FDA, Ronald Johnson, director of the Center for Devices and Radiological Health's Office of Compliance, said Jan. 25 at the BioEast conference in Washington, D.C. "What [the Office of Device Evaluation] and what we've been talking about doing is providing some kind of a mechanism to keep that 510(k) current," Johnson declared. "In other words, some kind of an annual report or a supplement or something, so that whether or not "a change itself necessitates a 510(k) submission," the file will be updated to accurately characterize the currently marketed device.
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