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Seven Accredited Bodies Recognized By FDA For 510(k) Third-Party Program

This article was originally published in The Gray Sheet

Executive Summary

FDA has deemed seven organizations eligible for participation in its "Accredited Persons" third-party review program. These seven may start accepting 510(k)s for devices that qualify for the program on Nov. 21, the day the program is mandated to begin under the FDA Modernization Act.
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