Posted by Michael Wonder on 04 Dec 2018
FDA proposes improvements to the De Novo pathway for novel medical devices to advance safe, effective, and innovative treatments for patients
4 December 2018 - Today, the U.S. FDA published the De Novo Classification Proposed Rule, which if finalized, would establish procedures and criteria for the De Novo classification process and become part of the Medical Device Classification Procedures.
The De Novo pathway is used for the review of novel, low to moderate risk devices for which general controls, or general and special controls, provide a reasonable assurance of safety and effectiveness, but for which there is no existing predicate to use in determination of substantial equivalence.
The proposed rule would, if finalised, facilitate appropriate classification of new types of medical devices. For example, the proposed regulations and requirements will provide structure, clarity and transparency on the De Novo classification process, including requirements related to the format and content of De Novo requests, as well as processes and criteria for accepting, granting, declining, and withdrawing De Novo requests.
