What is the range of time for the De Novo regulatory pathway?

The De Novo regulatory pathway is designed for medical devices that are considered to be of low to moderate risk but do not have a predicate device to compare against for approval. The typical timeframe for the De Novo review process is generally observed to be between 9 to 24 months. This period accounts for the complexity of reviewing new technologies and ensuring they meet safety and efficacy standards established by regulatory bodies.

The timeframe can vary based on several factors, including the amount of data provided for the new device, the thoroughness of the submission, and any additional questions or requirements that may arise during the review process. In some cases, the review could be expedited, but the average expected duration falls within the 9 to 24 months range, making this option the most accurate choice.