There will be no retaliation against companies who tell the U.S. Food and Drug Administration that its processes are too burdensome and unpredictable.
Those are the words of Jeffrey Shuren, director of the Center for Devices and Radiological Health at the FDA, according to a report by FDA News’ Device and Diagnostics Letter.
Last week, Shuren was at the annual meeting of the Medical Device Manufacturers where he said that CDRH staff would prefer to have companies come directly to them with complaints instead of avoiding those conversations for fear of retaliation from the agency.
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Shuren also candidly admitted that one study after another analyzing and criticizing the review process in recent months, combined with criticism from various groups in Washington, D.C., is affecting CDRH staff morale.
