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Congressmen question FDA handling of two devices, plan hearing on review process

This article was originally published in Clinica

Executive Summary

Members of the US energy and commerce committee have written to FDA acting commissioner Dr Joshua Sharfstein asking for the agency to re-examine its decision to approve a medical device manufactured by ReGen Biologics. The members of Congress say they are also planning to hold a hearing to examine the FDA’s process for evaluating the safety and efficacy of devices.

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