What is required for a device to be classified as a Class III medical device?

For a device to be classified as a Class III medical device, it must undergo premarket approval (PMA) due to higher risk factors. Class III devices are typically associated with the highest level of risk to patients, meaning that they are often life-sustaining, or are implanted or present a potential risk of illness or injury. The PMA process is rigorous and requires extensive clinical data to demonstrate the device's safety and effectiveness. This premarket approval serves as a safeguard to ensure that only the devices that meet strict standards for safety and efficacy can be marketed.

While prior paths for device approval exist, such as the 510(k) application for Class I and II devices, Class III devices do not qualify for this process as they present significant risks that necessitate the more thorough examination provided through PMA. Meeting performance standards set by ISO and manufacturing in a certified facility are important aspects of regulatory compliance but do not define the necessity for PMA on their own.