View Rule

De Novo classification decreases regulatory burdens because manufacturers can use a less burdensome application pathway under the FD&C Act to market certain devices. The rule would establish procedures and criteria for the De Novo process and would make it more transparent and predictable for manufacturers. By clarifying and making more efficient the De Novo request requirements, we expect the rule would reduce the time and costs associated with reviewing De Novo requests and generate net benefits in the form of cost savings.