How do Good Laboratory Practice (GLP) Regulations Apply to Medical Devices? This article first appeared in Medical Product Outsourcing, September 2014. Please visit the MPO site to view the original article. A question frequently asked by medical device designers is how and when GLP regulations apply to medical device studies. GLPs, short for Good Laboratory Practices, are the regulatory standards that define the minimum requirements for planning, conducting, and reporting nonclinical safety studies. There is significant confusion about what constitutes "best practices" for MedicGLP Supplement applying GLP to medical device studies. Likely, this is because the regulations, which were written primarily to apply to nonclinical studies of chemicals and pharmaceuticals, are now being applied to a greater variety of studies - including PMA submissions and medical device biocompatibility studies in support of 510k submissions. Some study sponsors are even requesting that sterilization validation studies be conducted according to GLP. Unfortunately, the GLP regulations have not been modified to reflect this expanded scope, leaving us to use our best judgment as to when GLP should be applied, and how the language in the GLP regulations corresponds to medical device studies.
What medical device studies should be conducted GLP? What characterization data of a medical device is needed when conducting a GLP study? Before we attempt to answer these two questions, let’s first examine what the GLP regulations are really about. GLP regulations were created in response to a lack of consistency and quality in the conduct of studies performed to assess the safety of chemicals that humans might be exposed to, as well as the safety of drugs prior to initiation of first-in-human studies. During the 1970s, severe deficiencies in the conduct of nonclinical toxicological studies were uncovered in many labs - the most notable and Medic GLP Website egregious example being the Industrial Bio-Test Laboratories scandal, where 71% of studies audited by the FDA were invalidated for falsified or incorrectly gathered data. Evidence of toxicity was covered up by changing results. The GLP regulations govern specifically how nonclinical studies must be performed - which is important because many types of studies do not need to be conducted according to the strict GLP guidelines.
Essentially, GLP was created to govern nonclinical studies conducted to assess the safety of a chemical or drug, prior to any human exposure. Upon adoption by the FDA, the GLP regulations were also applied to PMA submissions for devices, and have since been extended to apply to studies supporting 510k submissions as well. The GLP regulations are extensive, and lay out requirements for the controls that any facility performing GLP studies must enact to be compliant, and to ensure solid scientific data from nonclinical studies. GLP was designed to guarantee that results from nonclinical studies could be verified, would be repeatable, and would produce sound, scientifically valid data. This is ensured by requiring that testing facilities conform to standards, have an independent Quality Assurance Unit to assure the integrity of studies, and appoint a knowledgeable and trained Study Director to oversee the study and interpret the test results. Which Medical Device Studies should be Conducted According to GLP? Now to answer our initial questions.
First, which medical device studies must be conducted according to GLP, and when is GLP unnecessary? It is clear as to what types of studies of pharmaceuticals and biopharmaceuticals must be conducted according to GLP. For medical device studies the situation is less clear. To better understand the issue, let’s consider the concept of intrinsic safety. Intrinsic safety can be thought of as the safety of the device itself, in its final form. A device that is intrinsically very safe to use in humans (for instance, a plastic adhesive bandage) can be unsafe for use if it is not sterile when applied to a wound. An intrinsically unsafe device might, for example, be made of a material with a high toxicity. No amount of sterilization will render that device safe to use in humans. With this understanding, we will next look at three classes of studies, and discuss whether GLP should apply to those studies.