On August 27, 2013, the U.S. Food and Drug Administration (FDA) issued written guidance concerning device testing practices, which were initially promulgated in 1978. Seeking to address common questions about the scope of the regulations, FDA advised that adherence to “Good Laboratory Practices (GLP),” as detailed in FDA’s Compliance Program Guidance Manual, is not required in the earliest stages of non-clinical research and testing by device manufacturers. Specifically, FDA explained that “[b]asic 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.”

Despite FDA’s clarification concerning acceptable deviation from GLP parameters, qualifying research and testing is far from unregulated and must still conform to strong professional standards. According to FDA’s pronouncement, “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.”