New US Guidance on Good Laboratory Practice Compliance for 510(k) and PMA Submissions
New draft guidance from the US Food and Drug Administration addresses how Good Laboratory Practice for Nonclinical Laboratory Studies Regulations (GLP) applies to medical device manufacturers attempting to register their products.
According to the guidance, GLP compliance is required for any type of premarket submission that includes nonclinical laboratory studies to support research or marketing claims. The guidance defines nonclinical laboratory studies as experiments to determine a device’s safety—in vivo and in vitro biocompatibility and animal studies, for example. Clinical studies, bench tests, nonclinical feasibility and nonclinical effectiveness studies do not require GLP compliance.
- US regulators currently do not require compliance certification for GLP, but firms must appoint quality assurance units to monitor studies and ensure conformance with GLP regulations
- Final study reports must also include signed quality assurance statements either attesting to GLP compliance or citing valid reasons for GLP noncompliance
- Nonclinical laboratory studies conducted outside the US must also meet GLP requirements if those study results are used to support Premarket Approval (PMA) applications
Testing facilities for nonclinical laboratory studies are subject to audits and inspections by the FDA for GLP compliance, as well. Manufacturers should conduct proper due diligence to ensure their selected testing facilities allow FDA inspections, because any study conducted at a site that does not permit such inspections will not be accepted as part of a premarket submission.