Competitive Enterprise Institute Criticizes the FDA

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The Competitive Enterprise Institute, a conservative think tank, criticizes the FDA's medical device review process in a new report, a MassDevice report said.

Larry Pilot wrote the report, titled "Stifling Medical Device Innovation: A Response to Critics of the FDA's 510(k) Clearance Process." Mr. Pilot is a lawyer and pharmacist and pioneered the FDA's Office of Medical Devices more than 40 years ago.

In the report, Mr. Pilots recommends stricter oversight of the FDA and its Center for Devices & Radiological Health. He also states that the FDA too often requires clinical trials. For this and other reasons, he said, the FDA and advocacy groups are smothering new medical technology.

Related Articles on the FDA:
FDA, CMS Launch Pilot Program for Voluntary Review of Innovative Devices
Northwestern Researchers Compare Findings With IOM 510(k) Report
FDA Forms Expert Panel to Speed up Device Approval


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