FDA Issues Draft Q-and-A Document On Good Lab Practices, Medical Devices

The Food and Drug Administration Aug. 27 released a draft guidance intended to explain to manufacturers how good laboratory practice (GLP) standards can apply to nonclinical laboratory studies conducted in support of research and marketing applications for medical devices.

The draft guidance provides clarification on GLP terminology, the types of medical device research or marketing applications that are subject to the GLP regulation, and, if applicable, the types of information related to GLP that should be provided to FDA.

In an Aug. 28 Federal Register notice (78 Fed. Reg. 53,151), FDA said comments on the draft are due Nov. 26 ...