WHAT IS THE 510(K) AND HOW HAS IT CHANGED SINCE ITS CONCEPTION?

The 510(k) has become the most frequently followed pathway in the process of getting a medical device or technology to market. What largely began as a pathway meant to simplify the process of allowing devices to enter the market without compromising quality or imposing risk has recently gained more and more attention for the consequences and lives lost due to its presence. But do the lives lost due to devices entering the market through this pathway outweigh the number of lives saved due to devices entering the market through this pathway, or the invisible lives that would’ve been lost had a more time-consuming approval process been undertaken? Within this review are discussed the often-contrasting points for and against the 510(k) pathway for patients and medical device manufacturers, the realized and potential impacts of updates made to the 510(k) since its conception, and suggestions for improving the current 510(k) process.