Which of the following describes a significant risk device?

A significant risk device is characterized by its potential to pose serious risks to patient health and safety. An implant that has the possibility of causing serious harm if it fails or is used improperly fits this definition perfectly. Such devices are subjected to more stringent regulatory controls, including premarket approval by the FDA, because of the implications they have on health outcomes.

This categorization ensures that devices with the potential for profound negative consequences receive the necessary scrutiny during development and marketing, thereby safeguarding public health. In contrast, other types of devices, such as those intended solely for cosmetic enhancements or administrative functions, do not inherently carry the same level of risk and are thus classified differently under regulatory definitions. Furthermore, devices not intended to support or sustain life may also be lower risk, focusing on less critical aspects of health.