Non-significant Risk Medical Devices

The development and introduction of medical devices into the market necessitate comprehensive evaluation to ensure their safety and effectiveness. Within the realm of medical device regulation, certain devices are classified as non-significant risk (NSR) devices, indicating that they pose minimal risk to the health, safety, and welfare of individuals participating in clinical investigations. Understanding the regulatory framework surrounding NSR devices is crucial for manufacturers, researchers, and health-care professionals involved in their development and evaluation. This chapter provides an overview of the regulatory considerations and clinical investigation requirements outlined in 21 CFR Part 812 for NSR devices.