Today, the U.S. Food and Drug Administration 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 (21 CFR Part 860). 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 finalized, 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.

The De Novo Classification Proposed Rule issued today builds on FDA’s earlier work to provide structure, clarity, and transparency to the De Novo classification pathway. In 1997, through the Food and Drug Administration Modernization Act (FDAMA), the FDA was first able to classify novel, low to moderate risk devices without a predicate as a class I or class II device through De Novo classification. Prior to FDAMA, all new devices without a predicate were automatically classified into class III and subject to premarket approval (PMA) regardless of level of risk the product posed or the ability of general and special controls to assure safety and effectiveness. In 2012, under the Food and Drug Administration Safety and Innovation Act (FDASIA), the FDA made further modifications to the De Novo process, which helped streamline and increase efficiency of the De Novo pathway. Most recently, in 2017, the FDA issued final guidance on the process for the submission and review of a De Novo request.

Since the FDA began granting marketing authorization for De Novo devices, there have been marketing authorizations for 235 safe and effective novel medical devices through this pathway, 170 of which have occurred after 2012. Among the De Novo requests that the FDA granted in 2017 and 2018, were the first self-fitting hearing aid, the first mobile app to help treat substance use disorders, the first artificial intelligence (AI)-based software used to detect more-than-mild diabetic retinopathy, and the first test to identify the emerging pathogen Candida auris, which causes serious infections in hospitalized patients.

The proposed rule issued today embodies the goal of pursuing greater efficiency in the De Novo classification process set forth in the Medical Device User Fee Amendments 2017 (MDUFA IV) Commitment Letter composed by FDA and industry representatives.

The proposed rule is available for public comment and will not be in effect until finalized. The FDA welcomes comments from stakeholders regarding this important step in bringing greater structure, clarity and efficiency to medical device regulation.