The "de Novo" 510(k) Process and the Reclassification of Class III Devices

For medical device makers today, a major challenge of the Device Amendments  of 1976 is resolving the conflict between the need to be innovative -- an essential for patent protection -- and the fact that, if they are, their device may automatically fall into Class III and require premarket approval rather than being marketed via the "substantially equivalent" route of the 510k submission. This article discusses this tensino and a mechanism the law now provides for device makers to resolve the conflict and avoid the more onerous premarket approval process.