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ODE Chief Tillman Defends 510(k) Program At Minnesota Industry Meeting

This article was originally published in The Gray Sheet

Executive Summary

FDA's head of device evaluation is defending the agency's handling of 510(k) pre-market notification submissions in the face of criticism from two groups: those who charge the agency has allowed devices on the market without sufficient scientific evidence, and industry representatives who claim that FDA often demands too much from 510(k) applicants

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