510(k)s Are Subject To Good Laboratory Practice Regs – FDA Draft Guidance

Article preview from Medtech Insight - September 27, 2013

Device manufacturers must declare compliance or explain noncompliance to good laboratory practice regulations for nonclinical studies in all premarket submission types, according to new draft guidance.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510(k)s Are Subject To Good Laboratory Practice Regs – FDA Draft Guidance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 Medtech Insight - September 27, 2013

All premarket device submissions, including 510(k)s, are subject to Good Laboratory Practice (GLP) regulations and must include statements addressing GLP compliance, according to draft guidance released August 28. This represents a new requirement for 510(k)s, says a former CDRH official from the Food and Drug Administration’s (FDA’s) Center for Devices and Radiological Health (CDRH) 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 premarket 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The new draft guidance says that GLP regulations apply to nonclinical lab studies that support all submission types, including 510(k), Premarket Approval (PMA), humanitarian device exemption, and investigational device exemption applications.

Continued...

To read this article in its entirety, purchase now, as a PDF and recieve it immediately via email. Or get it free when you subscribe to Medtech Insight Newsletter.

About Medtech Insight

Medtech Insight newsletter provides insights into the technology and market developments (devices, instrumentation, biomaterials, gene therapy, tissue engineering, etc) impacting a wide range of surgical and non-surgical clinical practices.