People often think that a medical device is safe because it is approved by the FDA. Unfortunately, this is not the case. There are two ways for device manufacturers to obtain approval to market their products: Premarket Approval and 510(k) Premarket Notification.
The first and most stringent is through the Premarket Approval process (“PMA”). PMA requires a manufacturer to submit clinical evidence of the safety and effectiveness of a device in support of its application for approval. A device manufacturer must conduct clinical trials and submit the results to the FDA. PMA is used for Class III devices, or those that pose a “significant risk” to users: pacemakers, ventilators, implants, etc.
510(k) Premarket Notification
The less strict and more common method is through the 510(k) Premarket Notification process (“510(k)”). This requires a manufacturer to notify the FDA that it intends to market a medical device in 90 days. The FDA determines whether the device is substantially equivalent to a device already on the market. “Substantially equivalent” means it has the same intended use and same technology as a prior device, or it uses different technology but does not raise different questions of safety and effectiveness. The manufacturer is not required to submit evidence that the product is safe.
The 510(k) process is used primarily for approval of Class I and Class II medical devices. Class I devices pose a “minimal risk” to users: bandages, latex gloves, dental floss, etc. Most Class I devices are exempt from the 510(k) process altogether. Class II devices pose a “moderate risk” to users: pregnancy tests, sutures, etc.
This more lenient process makes sense for Class I and Class II devices, but oftentimes Class III devices also obtain market clearance through the less strict 510(k) process. This makes less sense, as one would think that proving the safety of such high-risk devices prior to approval would be would be paramount.
For example, many vaginal mesh implants were approved through the 510(k) process. One of the first mesh devices was approved based on its similarity to a mesh used in cardiovascular grafting. The FDA did not perform a formal review or require proof of safety of human implantation.
Other manufacturers continued to gain 510(k) approval using that product as the predicate device, flooding the market with unsafe vaginal mesh products. As many of our clients know, the results were disastrous.