In December 2018, the Food and Drug Administration issued a proposed rule that would amend the medical device classification regulation to implement the De Novo classification process. In short, the notice explains FDA’s thinking, and the rule, if finalized as proposed, would formally implement the law on the submission and withdrawal of requests for De Novo classification. Furthermore, the rule would set the criteria used by the agency when reviewing, approving, rejecting, or withdrawing these requests. FDA will accept comments submitted by March 7, 2019.
This Bulletin summarizes some of the key provisions of the proposed rule.
advertisements for the device.
In order to be accepted for substantive review, a De Novo request must include all required information (i.e., meet the content requirements).