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Third-party 510(k) pilot program may include all non-exempt Class I devices -- FDA's Levitt.

This article was originally published in The Gray Sheet

Executive Summary

CDRH THIRD-PARTY PILOT MAY INCLUDE ALL CLASS I DEVICES that are not already exempt from 510(k) requirements, Joseph Levitt, deputy director for regulations and policy at FDA's Center for Devices and Radiological Health, told the Food and Drug Law Institute Educational Conference Dec. 13. "There was a great interest to expand the base of devices, especially in vitro diagnostics, and so we are now looking at including all of the remaining Class I devices -- which is heavily influenced by" IVDs -- in the third-party pilot.



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