Groundbreaking technologies are altering the very definition of what is considered a medical device, and these dynamic changes necessitate the evolution of medical device clinical trials. Wearables, Software as a Medical Device (SaMD) products, and other innovations are transforming the regulatory landscape. At this rapidly accelerating pace, conducting clinical investigations for a new device in accordance with the latest regulatory requirements and industry standards is a challenge. It often seems that the speed of innovation is far outpacing regulators’ ability to provide up-to-date clinical guidance, which creates ambiguity. To minimize uncertainty and start getting a feel for the current regulatory climate, it’s helpful to first examine some of the characteristics that distinguish medical device clinical trials from other clinical investigations.
Because medical devices are inventions that function physically, they are subject to unique regulations that are different from those that apply to pharmaceutical products, which are typically discoveries that function biologically or chemically. That being the case, the regulatory journey of a medical device will vary — sometimes subtly and sometimes drastically — from that of a drug. Consider the following five ways clinical trials for medical devices differ from those conducted for drug products:
For a deeper look into the significant differences between drug and medical device clinical trials, check out the article “How to Conduct a Well-Controlled Clinical Trial.”
Two main regulations apply to the conduct of medical device clinical trials. Devices sold or manufactured in the U.S. are regulated by the U.S. Food and Drug Administration (FDA). Global standards are set by the International Organization for Standardization (ISO).
U.S. Regulations – Title 21 of the Code of Federal Regulations
The FDA regulations for clinical devices are outlined in Title 21 of the Code of Federal Regulations, aka 21 CFR. These regulations and requirements must be adhered to while conducting clinical trials for medical devices, and they are commonly referred to as Good Clinical Practices (GCP):
Global Standards – ISO 14155
The global standard that addresses GCP for medical device clinical trials is ISO 14155. It sets forth guiding principles for the design, conduct, recording, and reporting of clinical investigations carried out in human subjects to assess the clinical performance or effectiveness and safety of medical devices. The ISO 14155 standard has many overlaps with FDA regulations and specifies the requirements that are generally applicable to the four core facets of medical device clinical trials:
Updates to ISO 14155 were issued in 2020 to refine the standard’s focus on clinical evidence, data reliability, and increasing safety, among other reasons. In addition, the new version is more closely aligned with other widely recognized clinical directives such as the ICH E6(R2) GCP guideline, the European Medical Device Regulation (EU MDR), and the Declaration of Helsinki.
Whereas the previous version of ISO 14155 placed greater emphasis on identifying risk of failures rather than proactive measures, the 2020 updates add new directives that promote a risk-based approach to clinical investigations. The standard now calls for the development of a risk management plan that should be incorporated into the study protocol before the study begins and followed throughout the product life cycle. The updated standard also points to a need for more effective corrective action / preventive action (CAPA) management in cases of significant noncompliance and for device deficiencies that occur during the course of clinical investigation of medical devices. (2)
The information presented in this article is only a broad overview of the dynamic and complex world of medical device clinical trials. For a more comprehensive exploration of clinical trials for medical devices, download the white paper “The Evolution of Medical Device Clinical Trials: Their Background and a Look Toward the Future.”
Enjoying this blog? Learn more.
The Evolution of Medical Device Clinical Trials: Their Background and a Look Toward the FutureGet the White Paper