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Federal Register / Vol. 86, No. 190 / Tuesday, October 5, 2021 / Rules and Regulations
a proposed rule or modification by issuing an order within 60 days of the date the proposed rule or modification was published in the Federal Register for public comment.
b Standard of review. The Commission will approve a proposed rule or modification if the Commission finds that the proposed rule or modification is consistent with the Act and the applicable rules approved by the Commission. If the Commission disapproves a rule or modification, it will make recommendations to the Authority to modify the proposed rule or modification within 30 days of such disapproval.
c Effect. A proposed rule or modification will not take effect unless it has been approved by the Commission.
By direction of the Commission.
April J. Tabor, Secretary.
FR Doc. 202121306 Filed 10421; 8:45 am BILLING CODE 675001P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES

Table of Contents
Food and Drug Administration 21 CFR Part 860
Docket No. FDA2018N0236
RIN 0910AH53

Medical Device De Novo Classification Process AGENCY:

Food and Drug Administration,
HHS.
ACTION:

Final rule.

The Food and Drug Administration FDA is issuing a final rule to establish requirements for the medical device De Novo classification process under the Federal Food, Drug, and Cosmetic Act FD&C Act. This final rule establishes procedures and criteria related to requests for De Novo classification De Novo request and provides a pathway to obtain marketing authorization as a class I or class II
device and for certain combination products. These requirements are intended to ensure the most appropriate classification of devices consistent with the protection of the public health and the statutory scheme for device regulation. They are also intended to limit the unnecessary expenditure of FDA and industry resources that may occur if devices for which general controls or general and special controls provide a reasonable assurance of safety
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and effectiveness are subject to premarket approval. The final rule implements the De Novo classification process under the FD&C Act, as enacted by the Food and Drug Administration Modernization Act of 1997 FDAMA
and modified by the Food and Drug Administration Safety and Innovation Act FDASIA and the 21st Century Cures Act Cures Act.
DATES: This rule is effective January 3, 2022.
ADDRESSES: For access to the docket to read background documents or comments received, go to https
www.regulations.gov and insert the docket number found in brackets in the heading of this final rule into the Search box and follow the prompts, and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 2404027500.
FOR FURTHER INFORMATION CONTACT:
Sergio de del Castillo, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 2431, Silver Spring, MD 20993, 301796
6419.
SUPPLEMENTARY INFORMATION:
I. Executive Summary A. Purpose of the Final Rule B. Summary of the Major Provisions of the Final Rule C. Legal Authority D. Costs and Benefits II. Table of Abbreviations/Commonly Used Acronyms in This Document III. Background A. Need for the Regulation/History of This Rulemaking B. Summary of Comments to the Proposed Rule C. General Overview of Final Rule IV. Legal Authority V. Comments on the Proposed Rule and FDA
Response A. Introduction B. Description of General Comments and FDA Response C. Comments and FDA Response on Use of Advisory Committees and Bundling Devices D. Comments and FDA Response on De Novo Request Information Disclosure E. Comments and FDA Response on Facility Inspections F. Comments and FDA Response on Definitions G. Comments and FDA Response on De Novo Request Format H. Comments and FDA Response on De Novo Request Content I. Comments and FDA Response on Criteria for Accepting a De Novo Request J. Comments and FDA Response on Criteria for Granting or Declining a De Novo Request K. Comments and FDA Response on Availability of the De Novo
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Classification Process for Combination Products VI. Effective Date VII. Economic Analysis of Impacts VIII. Analysis of Environmental Impact IX. Paperwork Reduction Act of 1995
X. Federalism XI. Consultation and Coordination With Indian Tribal Governments XII. References
I. Executive Summary A. Purpose of the Final Rule This rule establishes new regulations implementing the medical device De Novo classification process under the FD&C Act, which provides a pathway for certain new types of devices to obtain marketing authorization as class I or class II devices, rather than remaining automatically designated as a class III device, which would require premarket approval under the postamendments device classification section of the FD&C Act.
The De Novo classification process is intended to provide an efficient pathway to ensure the most appropriate classification of a device consistent with the protection of the public health and the statutory scheme for device regulation. When FDA classifies a device type as class I or II via the De Novo classification process, other manufacturers do not necessarily have to submit a De Novo request or premarket approval application PMA
to legally market a device of the same type. Instead, manufacturers can use the less burdensome pathway of premarket notification 510k, when applicable, to legally market their device, because the device that was the subject of the original De Novo request can serve as a predicate device for a substantial equivalence determination.
B. Summary of the Major Provisions of the Final Rule This rule establishes procedures and criteria for the submission and withdrawal of a De Novo request. It also establishes procedures and criteria for FDA to accept, review, grant, and/or decline a De Novo request. While several comments object to sections or subsections of the proposed rule, almost all comments voice support for the objective of the proposed rule: To establish regulations implementing the De Novo classification process. The rule provides that:
A person may submit a De Novo request after submitting a 510k and receiving a not substantially equivalent NSE determination.
A person may also submit a De Novo request without first submitting a 510k, if the person determines that
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