Medical Device De Novo Classification Process rule (2022)
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The Medical Device De Novo Classification Process rule is a significant rule issued by the Food and Drug Administration (FDA) effective January 3, 2022, that set new regulations surrounding the medical device De Novo classification process under the Federal Food, Drug, and Cosmetic Act of 1938 (FD&C). De Novo classification gives certain new types of devices marketing authorization as class I or class II devices so that it is not automatically designated as a class III device, which needs premarket approval under the FD&C.[1]
Timeline
The following timeline details key rulemaking activity:
- January 3, 2022: The final rule took effect.[1]
- October 5, 2021: The FDA issued the final rule.
- March 7, 2019: The FDA closed the comment period.
- December 7, 2018: The FDA issued the proposed rule and opened the comment period.[1]
- May 28, 1976: The Medical Device Amendments are passed, requiring the FDA to classify medical devices according to their safety for human use. [2]
- June 25, 1938: Federal Food, Drug and Cosmetics Act passed, giving FDA authority over the sale of medical devices.[3]
Background
The FDA issued the Medical Device De Novo Classification rule to create a more efficient way for medical devices to gain class I or class II market authorization, meaning the devices do not need premarket approval by the FDA. The rule aims to decrease inefficiencies in time and resources that go into certifying general devices for premarket approval. This rule came after the Food and Drug Administration Modernization Act of 1997 (FDAMA), which modified the Federal Food, Drug and Cosmetic Act (FD&C Act) that required the FDA to classify all medical devices according to safety for human use. [1]
Summary of the rule
The following is a summary of the rule from the rule's entry in the Federal Register:
| “ | 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 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 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).[1][4] | ” |
Summary of provisions
The following is a summary of the provisions from the rule's entry in the Federal Register:[1]
| “ | 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 510(k) and receiving a not substantially equivalent (NSE) determination. A person may also submit a De Novo request without first submitting a 510(k), if the person determines that there is no legally marketed device upon which to base a determination of substantial equivalence (SE). FDA will classify devices according to the classification criteria in the FD&C Act. FDA classifies devices into class I (general controls) if there is information showing that the general controls of the FD&C Act are sufficient to reasonably assure safety and effectiveness; into class II (special controls) if general controls, by themselves, are insufficient to provide reasonable assurance of safety and effectiveness, but there is sufficient information to establish special controls to provide such assurance; and into class III (premarket approval) if there is insufficient information to support classifying a device into class I or class II and the device is a life-sustaining or life-supporting device or is for a use which is of substantial importance in preventing impairment of human health or presents a potential unreasonable risk of illness or injury. Devices will be classified by FDA by written order. A De Novo request includes administrative information, regulatory history, device description, classification summary information, benefits and risks of device use, and performance data to demonstrate reasonable assurance of safety and effectiveness. FDA may refuse to accept a De Novo request that is ineligible or that is not sufficiently complete to permit a substantive review. After a De Novo request is accepted, FDA will begin a substantive review of the De Novo request that may result in either FDA requesting additional information, issuing an order granting the request, or declining the De Novo request. FDA may decline a De Novo request if, among other things, the device is ineligible or insufficient information is provided to support De Novo classification. The rule also describes our practices for the conditions under which the confidentiality of a De Novo file is maintained.[1][4] |
” |
Significant impact
- See also: Significant regulatory action
Executive Order 12866, issued by President Bill Clinton (D) in 1993, directed the Office of Management and Budget (OMB) to determine which agency rules qualify as significant rules and thus are subject to OMB review.
Significant rules have had or might have a large impact on the economy, environment, public health, or state or local governments. These actions may also conflict with other rules or presidential priorities. Executive Order 12866 further defined an economically significant rule as a significant rule with an associated economic impact of $100 million or more. Executive Order 14094, issued by President Joe Biden (D) on April 6, 2023, made changes to Executive Order 12866, including referring to economically significant rules as section 3(f)(1) significant rules and raising the monetary threshold for economic significance to $200 million or more.[1]
The text of the Medical Device De Novo Classification Process states that OMB deemed this rule significant, but not economically significant:
| “ | Executive Orders 12866 and 13563 direct us to assess all costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity). We believe that this final rule is a significant regulatory action as defined by Executive Order 12866.[1][4] | ” |
Text of the rule
The full text of the rule is available below:[1]
See also
External links
Footnotes
- ↑ 1.0 1.1 1.2 1.3 1.4 1.5 1.6 1.7 1.8 1.9 Federal Register, "Medical Device De Novo Classification Process", November 1, 2023.
- ↑ U.S. Food and Drug Administration, "A History of Medical Device Regulation & Oversight in the United States", November 1, 2023.
- ↑ U.S. Food and Drug Administration, "Part II: 1938, Food, Drug, Cosmetic Act", November 1, 2023.
- ↑ 4.0 4.1 4.2 Note: This text is quoted verbatim from the original source. Any inconsistencies are attributable to the original source.
