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OCS letter to industry

This article was originally published in The Gray Sheet

Executive Summary

Center for Devices and Radiological Health's office of compliance and surveillance sends letter to roughly 20,000 device manufacturers on Jan. 21 to clarify and solicit industry input on OCS initiatives. FDA says that it has advised field offices that FDA-483 citations "regarding the need for new 510(k)s or premarket approval application supplements because of changes to the device should not be made unless approved by CDRH." In addition, revision of the 510(k) regulations to require manufacturers to provide current information on device manufacturing and sterilizing locations "is under consideration," the letter says. The letter also explains OCS' "reference list," discusses fiscal year 1992 enforcement statistics, and provides updates on development of a revised good manufacturing practices regulation and enforcement of germicide manufacturers. Future letters may cover topics such as compliance policy guides under development and bioresearch monitoring....

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