Certified Healthcare Leader (CHL) Exam 2026 – 400 Free Practice Questions to Pass the Exam

Class III medical devices are those that are typically more complex and are associated with a higher risk to the patient. They usually require pre-market approval by the FDA because they are intended to support or sustain human life, are of substantial importance in preventing impairment of human health, or present a potential unreasonable risk of illness or injury.

Heart valves and pacemakers are classic examples of Class III medical devices. These devices are not only vital for sustaining life but also involve intricate mechanisms to ensure they function properly in the human body. Their design and construction must meet stringent regulatory requirements to ensure patient safety and effectiveness.

Other options listed do not fall under Class III. For instance, hand-held surgical instruments and needles and syringes are typically classified as Class I or Class II devices, which require less regulatory scrutiny. Biological indicators are also considered Class II devices used primarily to test sterilization processes, further distinguishing them from the high-risk category of Class III devices.