What Are Clinical Investigations?
Clinical investigations for medical devices are systematic studies in one or more human subjects, undertaken to assess the clinical performance, effectiveness, and/or safety of a medical device (ISO 14155). In this way, the clinical investigation of a device ensures that the final device design meets user needs, intended uses, and any other requirements.
Investigational Device Exception (IDE) allows the device to be used in a clinical study to collect safety and effectiveness data in the United States. Clinical investigation studies are often conducted to support a PMA, De Novo or, in some cases, 510(k) submissions. All medical device clinical investigations require an approved IDE before initiating the study unless exempt.
Good Clinical Practices (GCP) refers to the regulations and requirements that must be adhered to while conducting a clinical study. The FDA defines GCP as “a standard for the design, conduct, performance, monitoring, auditing, recording, analysis, and reporting of clinical investigations in a way that provides assurance that the data and results are credible and accurate and that the rights, safety, and well-being of subjects are protected.” The primary regulations that govern clinical study conduct are included in 21 CFR part 812. This regulation is consistent with the other FDA related regulations (21 CFR parts 50, 56, and 812), as well as international ethical and policy standards for clinical trials. These international standards include ICH E6, the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use – Good Clinical Practice: Consolidated Guideline, and ISO 14155, the Clinical Investigation of Medical Devices for Human Subjects—Good Clinical Practice.