The FDA has issued a final rule aimed at simplifying the de novo classification process for medical devices.
In publishing the final rule yesterday, the FDA established procedures and criteria for submitting and withdrawing a de novo request while also setting guidelines for the FDA to decide on such a request. The changes matter because de novo allows some medical devices to leapfrog the premarket approval process.
FDA said that, while several comments object to sections or subsections of the proposed rule, almost all comments voice support for the objective of the proposed rule aimed at establishing regulations for the process.
Among the criteria in the rule is the stipulation that a person may submit a de novo request after submitting a 510(k) application and receiving a not substantially equivalent (NSE) determination. Additionally, a person may submit a de novo request without first submitting a 510(k), provided that there is no legally marketed device upon which to base a determination of substantial equivalence (SE).
FDA will classify devices into Class I (general controls), Class II (special controls) and cCass III (premarket approval), according to the rule. After a de novo request is accepted, the FDA will begin a substantive review of the request that could result in either the FDA requesting additional information, issuing an order granting the request or outright declining the request.
Despite some positive changes for medtech, the ruling also includes a less-than-popular FDA stipulation that the agency can carry out premarket manufacturing inspections. FDA’s argument is that such inspections are legal and necessary to the de novo process. Commenters argued that the provisions on inspections “are unduly burdensome or that FDA lacks statutory authority to require facility inspections.”