Class 3 Devices
Class 3 medical devices are the most innovative and invasive devices, which potentially present the highest risks to patient health and safety. This class constitutes approximately 10% of devices and includes devices like cochlear implants, defibrillators, and implanted prostheses.
The majority of Class 3 devices follow the PMA pathway. PMA is the agency’s process of scientific and regulatory review and the most stringent type of application possible. The PMA pathway involves presenting adequate scientific evidence to demonstrate safety and efficacy.
While preparing a PMA application is generally significantly more intensive than a 510(k) app or self-registration, it’s surprisingly not much longer of a wait post-submission. According to a report from the agency, the average PMA application is approved 243 days post-submission. That’s just over eight months, or 66 days longer than the average time to approval for a 510(k) application.
Class 3 medical devices are being approved faster than ever before. The agency has worked in recent years to improve the PMA pathway and reduce the wait time while maintaining a focus on patient safety. Prior to 2010, the average wait for a PMA approval was 345 days or nearly 12 months. That’s a speed-to-market increase of 111 days, on average, in the past nine years. Currently, 92% of PMA applications are approved by the agency.