FDA finalizes long delayed de novo classification rule

Regulatory NewsRegulatory News | 05 October 2021 |  By 

The US Food and Drug Administration (FDA) on Monday issued a final rule setting requirements for the medical device de novo classification process, codifying procedures and criteria for new types of medical devices to be authorized as Class I or Class II devices.
"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 recourses that may occur if devices for which general controls and special controls provide a reasonable assurance of safety and effectiveness are subject to premarket approval," FDA explains. The final rule will take effect in 90 days.
The final rule comes three years after FDA first proposed it, and its issuance has been on the agency's to-do list to finalize for the last two years. (RELATED: FDA proposes rule to implement new de novo classification process, Regulatory Focus 4 December 2018; Unified Agenda: A look at FDA’s upcoming rulemaking, Regulatory Focus 17 June 2021)
While the medical device industry has largely been supportive of FDA's proposed approach to de novo classifications, FDA rebuffed its request to limit premarket manufacturing inspections. In comments submitted to the proposed rule, industry group AdvaMed called on FDA to only conduct quality system and clinical data inspections after making a de novo classification decision, rather than beforehand as FDA proposed in some cases. (RELATED: Experts question FDA proposal to conduct manufacturing inspections for de novo reviews, Regulatory Focus 7 March 2019)
Those against FDA conducting inspections prior to a de novo decision argued that FDA does not have the statutory authority to do so and that such inspections would disrupt the timely review of de novo submissions and impose additional burdens on products that are seeking to be classified as low- to moderate-risk products.
Instead, in its final rule, FDA clarified that it would conduct facility inspections before making a de novo decision when it has data integrity or quality concerns and when there are novel or critical manufacturing processes that may impact device safety and effectiveness. "Based on past experience, inspections in these circumstances should arise with a small percentage of de novo requests," FDA said.
Additionally, FDA has revised some language in the section of the rule detailing the data and information required to be submitted in a de novo request. Some commenters took issue with FDA's requirement that requesters submit all "known or reasonably known" information relevant to the device. "In response to these comments, FDA is revising [the final rule] to clarify that the information required is that known to or that reasonably should be known to the requester," FDA writes. The agency further explains that the "intent of requiring a de novo request to include information that is known or reasonably known to the requester is to ensure that the requester engages in a reasonable effort to provide relevant information and does not omit information important to FDA's determination to grant or decline the de novo request because of a failure to conduct reasonable searches for such information."
FDA has also revised the final rule in response to comments received, "primarily for clarity and accuracy and to reduce burden in meeting regulatory requirements," and that it has made technical revisions throughout for improved clarity. The agency has also revised the rule to require information on previous requests for information on the class in which a device has been classified or the requirements applicable to a device submitted in accordance with section 513(g) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) to the regulatory history information required to be submitted in a de novo request. FDA notes that the latter change was included in the preamble of the proposed rule but was "inadvertently omitted from the proposed regulatory text."
Alongside the publication of the final rule, FDA has revised several of its guidances related to de novo classification to reflect the final rule coming into effect in 90 days. FDA notes that the references to 21 CFR Part 860 found within the guidances are not in effect until the effective date of the final rule. Those guidances include FDA and Industry Actions on De Novo Classification Requests: Effect on FDA Review Clock and Goals, De Novo Classification Process (Evaluation of Automatic Class III Designation), User Fees and Refunds for De Novo Classification Requests, and Acceptance Review for De Novo Classification Requests.


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