FDA Releases Draft Guidance on Good Lab Practices
Published: August 30th, 2013
[Targeted News Service] ARLINGTON, Va., Aug. 28 -- The Association for the Advancement of Medical Instrumentation issued the following news release:
In an effort to clear up confusion among medical device manufacturers about the applicability of good laboratory practice (GLP) regulations for nonclinical laboratory studies, the U.S. Food and Drug Administration (FDA) has issued draft guidance that answers questions the agency has fielded over the years.
The GLP regulations were adopted in 1978 in response to concerns over the conduct of studies supporting the safety of FDA-regulated products. They established the minimum requirements for study conduct, personnel, facilities, equipment, written protocols, operating procedures, study reports, and a system of quality assurance oversight, according to the draft guidance, titled The Applicability of Good Laboratory Practice in Premarket Device Submissions: Questions and Answers. GLP regulations apply to nonclinical laboratory studies--such as in vitro and in vivo biocompatibility testing and animal studies conducted to evaluate the potential for adverse responses to devices--used in support of a research or marketing application. The scope of the regulations is limited to safety studies performed on animals, plants, or microorganisms. They do not apply to studies with human subjects or specimens, clinical studies, or field trials in animals.
In the draft guidance, which was published in the Federal Register Aug. 28, the agency noted it has received numerous questions from device makers about GLP applicability, including whether animal, functional, or bench studies were subject to the regulations.
As the document noted, GLP regulations do not apply during the early phases of product development. "Basic exploratory studies carried out to determine whether a device has any potential utility, or to determine physical or chemical characteristics of a device, are not subject to the GLP regulations," according to the draft guidance. However, "the design and implementation of such studies should be based on good science, and data collection should be such that the integrity and quality of the study remain robust."
Another question the document answered was whether device makers need to submit a certification form demonstrating compliance with GLP regulations. The FDA said no, as facilities conducting such studies must have a quality assurance unit to ensure compliance.
The FDA also noted that nonclinical laboratory studies are subject to audits and inspections. "The FDA will not consider a nonclinical laboratory study in support of a research or marketing application if the testing facility refuses to permit [an] inspection," the draft guidance warned.
The FDA has asked interested parties to submit comments on the draft guidance by Nov. 26, 2013. To see the draft guidance, click here (PDF).( http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM366342.pdf)