510(k)s Are Subject To Good Laboratory Practice Regs – FDA Draft Guidance

Article preview from "The Gray Sheet" - September 2, 2013

 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to good laboratory practice regulations for nonclinical studies in all pre-market submission types, according to a new draft guidance.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.

510(k)s Are Subject To Good Laboratory Practice Regs – FDA Draft Guidance

Article preview from "The Gray Sheet" - September 2, 2013

All pre-market device submissions, including 510(k)s, are subject to Good Laboratory Practice regulations and must include statements addressing GLP compliance, according to draft guidance released Aug. 28. This represents a new requirement for 510(k)s, says a former CDRH official who specializes in 510(k) policy.

GLP regulations govern nonclinical laboratory studies supporting research or marketing applications for FDA-regulated products. They set forth the minimum requirements for study conduct, personnel, procedures and other components of a nonclinical study. But questions have surfaced in recent years over the applicability of GLP requirements in certain cases, particularly for 510(k) submissions.

FDA says the question-and-answer-formatted guidance on the applicability of GLPs to device submissions was developed in response to “a number of inquiries regarding whether specific device pre-market and research applications are subject to the GLP regulations. The agency has also received inquiries regarding whether specific nonclinical tests, e.g. animal studies, functional studies or bench studies, are subject to the GLP regulations.”

The new draft guidance says that GLP regulations apply to nonclinical lab studies that support all submission types, including 510(k), PMA, humanitarian device exemption and investigational device exemption applications.

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