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.
HOW TO SHORTEN THE FDA MEDICAL DEVICE APPROVAL PROCESS
Device class and approval pathway have a huge impact on the average length to wait for the FDA medical device approval process to complete. But is there anything you can control to speed up time-to-market? Your average wait can depend on how well you write your submission for any Class of device, and how well you “tick all the boxes” for your product by demonstrating substantial equivalence or proving safety and efficacy.
By Robert Fenton
Jinhua Huacheng Medical Appliance Co.,Ltd.
Manufactuer of disposable medical products: Electrosurgical pencil,grounding plate,skin stapler and ECG electrode
