Final answer:
A significant risk device, according to the FDA, refers to a medical device that carries a potential risk to the health, safety, or welfare of a patient and requires stricter regulatory controls to ensure its safety and effectiveness.
Step-by-step explanation:
A significant risk device, according to the FDA, refers to a medical device that carries a potential risk to the health, safety, or welfare of a patient and requires stricter regulatory controls to ensure its safety and effectiveness. These devices are usually implants, life-sustaining or life-supporting devices, or devices used in situations where there is a high risk of illness or injury.
Examples of significant risk devices include implantable cardiac defibrillators, neurostimulation systems, and certain types of prosthetics. These devices undergo a more rigorous review and clinical trials to demonstrate their safety and efficacy.
The FDA, through its Center for Devices and Radiological Health (CDRH), classifies medical devices into different categories based on the level of risk they pose. Significant risk devices fall under Class III, which requires the highest level of regulatory scrutiny.