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510(k)s Are Subject To Good Laboratory Practice Regs – FDA Draft Guidance

This article was originally published in The Gray Sheet

Executive Summary

Manufacturers must declare compliance or explain noncompliance to good laboratory practice regulations for nonclinical studies in all pre-market submission types, according to a new draft guidance. This has not been the requirement for 510(k)s up until now, says the former CDRH 510(k) policy chief.


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