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CLASS I, CLASS II 510(k) CLEARANCE NO LONGER LINKED TO GMP COMPLIANCE; FDA SHIFTING RESPONSIBILITY FOR GMP CONFORMANCE TO DEVICE MANUFACTURERS

This article was originally published in The Gray Sheet

Executive Summary

FDA is eliminating its pre-510(k) clearance good manufacturing practice check for Class I and Class II devices and is shifting responsibility for determining GMP compliance to manufacturers. On March 17, FDA Center for Devices and Radiological Health Director Bruce Burlington issued a memo to staff indicating that the agency is stopping its practice of checking to see if a company is in compliance with GMPs before clearing 510(k)s for Class I and Class II devices. The policy went into effect immediately.
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