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FDA to relax product modification regulations?

This article was originally published in Clinica

Executive Summary

US device manufacturers may no longer have to file a 510(k) when if they make substantial products modifications. A guidance document to be issued to FDA staff by the Center for Devices and Radiological Health urges leniency in dealing with companies already complying with the preproduction design controls required as part of the agency's new good manufacturing practices rule, says center director Bruce Burlington. Although the design portion of that rule does not come into effect until 1998, many companies will begin adopting it next year. With the design documentation available, a revised 510(k) submission would be redundant, claims the agency.

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