I believe the 510(k) is a reliable premarket screen of safety for moderate risk devices, and due to product and market innovations, the FDA continues to strengthen requirements for approval. The advantage of having a 510(k) in place is that it saves the PMA for higher risk devices that could not be tested for safety and efficiency with 510(k), a drawback would be the amount of time and effort that manufacturers have to put into a 510(k), for example the average number of pages required for a 510(k) is 1,000