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Senate committee hears former Center for Devices and Radiological Health (CDRH) head on FDA reform

This article was originally published in Clinica

Executive Summary

"The Medical Device Amendments law of 1976 ... does not have a stated purpose, does not explicitly offer a variety of non- regulatory tools to accomplish the mission and in fact is very prescriptive." In his testimony to the Senate hearings on Nancy Kassebaum's FDA reform bill, former director of the CDRH John Villforth emphasised the agency's main role in protecting public health. Unfortunately, he said, the FDA often sees regulation and compliance as the only means to achieve that goal.

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