FDA Regulation of Implantable Sensors: Demonstrating Safety and Effectiveness for Marketing in the U.S

Implantable sensors are gaining considerable attention in the research and medical communities due to their potential to enhance the detection and monitoring of medical conditions such as cancer, diabetes, and heart disease. The use of implantable sensors for these exciting applications bring them under the regulatory oversight of the United States Food and Drug Administration (FDA). As medical devices intended for long-term implantation that inherently involve some risk, the FDA will carefully evaluate these products prior to allowing them to enter the U.S. market. This paper provides a brief overview of the FDA medical device regulatory framework under which implantable sensors for medical purposes are regulated. It also addresses particular concerns the FDA may raise with respect to these products including, potential sensor breakage and migration in vivo , biocompatibility, electromagnetic compatibility, electromagnetic interference, wireless telemetry, risk/benefit, and clinical utility.