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DCRND GROUP LEADERS GET 510(K) CLEARANCE AUTHORITY UNDER REORGANIZATION

This article was originally published in The Gray Sheet

Executive Summary

DCRND GROUP LEADERS GET 510(K) CLEARANCE AUTHORITY UNDER REORGANIZATION of the Division of Cardiovascular, Respiratory, and Neurological Devices in FDA's Office of Device Evaluation. The 120-day pilot restructuring, implemented Sept. 1, gives leaders of four device review groups authority to sign off on all documents related to 510(k) decisions with the exception of not substantially equivalent (NSE) letters, which will still require the signature of DCRND Director Thomas Callahan. Previously, the DCRND director also signed off on standard substantial equivalence decisions and other documents such as "special routine letters" and 510(k)s with "unique responses."
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