What does a Class III device's PMA submission generally not require?

A Class III device typically presents a higher risk to patients and therefore requires a Pre-market Approval (PMA) submission to the regulatory authority, such as the FDA in the United States. The PMA process is comprehensive and demands a substantial amount of supporting data to establish the device's safety and effectiveness.

While the submission must include clinical data and complete manufacturing details, as well as a thorough risk analysis to inform decision-making about the device's safety and efficacy, it generally does not require preclinical testing results. Preclinical testing is usually more relevant for Class I and II devices, which can be assessed through other means such as 510(k) notifications. For Class III devices, the focus shifts considerably towards data derived from clinical studies because of the critical need to demonstrate safety and effectiveness in human populations.