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De novo classification decreases regulatory burdens because manufacturers can use a less burdensome application pathway under the FD&C Act to market their devices.  The proposed rule would establish procedures and criteria for the de novo process and would make it more transparent and predictable for manufacturers.

Statement of Need:

FDA is taking this action to implement amendments to the De Novo classification process in the FD&C Act that were enacted by the Food and Drug Administration Modernization Act of 1997 (FDAMA), and the Food and Drug Administration Safety and Innovation Act of 2012 (FDASIA), and the 21st Century Cures Act of 2016 (Cures).

Summary of the Legal Basis:

The FD&C Act (21 U.S.C. 301 et seq.), as amended, establishes a comprehensive system for the regulation of medical devices intended for human use.  Section 513 of the FD&C Act established three categories (classes) of medical devices based on the regulatory controls sufficient to provide reasonable assurance of safety and effectiveness of the device.  In 1997, Congress enacted section 513()(2) to include a De Novo classification process for some devices for which reasonable assurance of safety and effectiveness could be established through the De Novo process.  FDASIA and cures expanded and modified this process.

Alternatives:

The De Novo classification process is based on authority from the FD&C Act.  The De Novo classification program must continue because it is required by statute.  If the proposed rule is not finalized, then procedures and details about the application process and handling of De Novo applications might be unclear to potential applicants, and the program may not be as efficient as it might be.

Anticipated Costs and Benefits:

By clarifying the requirements for the De Novo classification process.  FDA expects that the rule would reduce the time and costs associated with preparing and reviewing De Novo requests, and would generate net benefits in the form of cost savings for both private and government sectors.

Risks: