The FDA defines Class III devices as products which “usually sustain or support life, are implanted or present a potential unreasonable risk of illness or injury."
Just 10 percent of the devices regulated by the US FDA fall into Class III. This classification is generally extended to permanent implants, smart medical devices, and life support systems.
While Class III is generally reserved for the most innovative and cutting-edge medical devices, there are other devices which can fall into Class III for different reasons. Some devices which are categorized initially as Class II may be bumped up to Class III if the manufacturer is unable to demonstrate substantial equivalence to a predicate (existing product) during the PMA (510k) filing process.
BRINGING CLASS III MEDICAL DEVICES TO MARKET
Class III devices are subject to all FDA General Controls and the FDA Premarket Approval (PMA) process. The FDA writes, "due to the level of risk associated with Class III devices, FDA has determined that general and special controls alone are insufficient to assure the safety and effectiveness of Class III devices."
The PMA is the most intensive type of device marketing application required by the FDA. Some FDA Class III devices are exempt and may qualify for a 510(k) filing, but the majority are expected to gain Premarket approval.
The PMA process requires a rigorous study of a medical device to prove safety and effectiveness through the development of a data-driven benefit/risk profile. The PMA process generally involves clinical trials and significant time and resources for sufficient data collection. The only exceptions to the PMA process within Class III are devices with a substantial equivalent. You can determine whether a Class III device can be marketed with a 510(k) by searching the FDA Premarket Approval (PMA) database and the 510(k) Premarket Notification database.
Jinhua Huacheng Medical Appliance Co.,Ltd.
Manufactuer of disposable medical products: Electrosurgical pencil,grounding plate,skin stapler and ECG electrode
