Medical Device Testing Company | Medical Device CRO

Meeting FDA Requirements for GLP Studies: A CRO Perspective

The ultimate goal for medical device or drug development is to get the product–one proven safe and effective–to market as quickly as possible.  In the U.S., this means an in-depth product testing and evaluation process using good laboratory practice (GLP) well within FDA regulations.  A contract research organization (CRO) like PMI Preclinical is uniquely qualified and adept at running preclinical trials for medical devices and new drugs that both meet FDA requirements and follow GLP.

FDA Requirements for GLP

Medical device testing companies must meet FDA requirements throughout every phase of the studies they conduct. This is also true when a new drug is being examined. Chapter I of Title 21 of the Code of Federal Regulations lays out the guidelines for new drug approval (in the 300 series) and for medical device testing and reporting (in the 800 series). These regulations include guidelines for pre-market approval and quality assurance systems among other requirements and can be quite complex.  Pharmaceutical and medical device contract research organizations, such as PMI, devote a great deal of attention to keeping abreast of these regulations and knowing how best to achieve strict compliance with FDA requirements.  This in turn smooths the pathway from model to clinical trials to marketplace.

For example, FDA regulations specify the roles and responsibilities of the personnel involved in a preclinical study, the definition of a test article (the drug or medical device being examined), the ways in which data will be collected, analyzed, interpreted, and archived, and the choice, treatment, and dispensation of the test subjects, among a host of other aspects of the study.  Premises, protocols, and equipment are subject to examination without notice, though new drug and medical device testing laboratories are routinely inspected for GLP every two to four years by the FDA.

As a CRO specializing in preclinical investigations of new drugs and medical devices, PMI is highly experienced with meeting FDA requirements for GLP studies. Medical device development companies must know both the general FDA requirements for preclinical (sometimes called nonclinical research), specific regulations pertaining to pharmaceutical products or medical devices, and both FDA and USDA regulations when working with animal test subjects.

Safety Testing Medical Devices and Pharmaceuticals

The two most important aspects of any preclinical trial are safety and efficacy.  If a medical device or drug is not found safe for use in animal models, the product cannot proceed to clinical trials on humans.  Also, if the product does not prove effective, investigation will end in the preclinical phase.  Both successes and failures must be documented according to FDA regulations, though in some cases the method of determination is not mandated.

A good example of this–in the case of medical device development–is biocompatibility testing.  Though the FDA requires an examination of how compatible a medical device is with the animal or human for which it is designed (even down to how the color of the device, especially implantables, may impact the end user), the methods used to make this determination are not fixed. A recent 2013 FDA document provides guidance as to how this examination may be achieved, though it leaves it up to the medical device testing company to choose the methodology, as long as the results of the testing prove valid, robust, and reproducible. Having the acumen, experience, and current information puts a CRO like PMI in the best position for making such important judgements, thereby saving the sponsoring organization time, effort, and money, and increasing the likelihood of pre-market approval.