Regulatory Counsel

0910-AH53 201810 The Regulatory Plan and the Unified Agenda of Federal Regulatory and Deregulatory Actions 0910 Food and Drug Administration FDA 0900 Department of Health and Human Services HHS Medical Device De Novo Classification Process

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.

]]> Other Significant Previously Published in The Unified Agenda Proposed Rule Stage Undetermined No Other 21 CFR 860 21 U.S.C. 321(h) 21 U.S.C. 360c, 360i-360j 21 USC 371 21 USC 374 Yes

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).

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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.

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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.

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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.

]]> ]]> NPRM 10/00/2018 No No None No No No No Laurie Sternberg Regulatory Counsel 0910 Food and Drug Administration FDA 240 402-0425 laurie.sternberg@fda.hhs.gov Suite 200N (HFM-630), 10903 New Hampshire Avenue, Building 66, Room 5517, Silver Spring MD 20993