White Paper – FDA Guidance Documents for De Novo Classification Requests

The De Novo classification process is a risk-based approach for classifying novel medical devices that had previously been automatically placed in Class III, the highest United States device classification.

On October 4, 2021, the US Food and Drug Administration (FDA) issued a final rule to set requirements for the medical device De Novo classification process. On October 5, 2021, FDA issued new versions of four Guidance Documents related to the De Novo Classification Process to align with the final rule. These Guidance Documents attempt to provide additional transparency regarding the De Novo classification process regarding user fees and refunds, expectations on content submission, and MDUFA review goals. This paper summarizes the content of each of the Guidance Documents.