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Sen. Kassebaum's FDA reform plan would not allow third-party sign-off on applications.

This article was originally published in The Gray Sheet

Executive Summary

SENATE FDA REFORM PLAN WOULD LEAVE DEVICE SUBMISSION SIGN-OFF POWER WITH FDA rather than giving final approval authority to third-party review organizations. Under a "concept paper" on the "FDA Performance and Accountability Act" floated by Sen. Nancy Kassebaum's (R-Kan.) Labor and Human Resources Committee, "FDA would retain final responsibility for the approval or disapproval" of premarket approval applications and 510(k)s.
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