FDA finalizes long-delayed de novo classification rule


Posted on October 05, 2021 | Through Michel mezher

The United States Food and Drug Administration (FDA) released final rule on Monday setting requirements for the medical device de novo classification process, codifying the 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 in accordance with the protection of public health and the statutory regulatory regime for devices. They are also intended to limit the unnecessary expense of FDA and industry remedies that may arise if devices for which general and special controls provide reasonable assurance of safety and efficacy are subject to pre-approval. marketing, ”says the FDA. The final rule will take effect in 90 days.

The final rule comes three years after the FDA first proposed it, and its publication has been on the agency’s to-do list to be finalized in the past two years. (RELATED: FDA proposes rule to implement new de novo classification process, Regulatory guidance December 4, 2018; Unified Agenda: An Overview of Upcoming FDA Regulations, Regulatory guidance June 17, 2021)

While the medical device industry has broadly supported the approach proposed by the FDA to de novo classifications, the FDA denied its request to limit pre-market manufacturing inspections. In comments subject to the proposed rule, industry group AdvaMed has asked the FDA not to perform quality system and clinical data inspections until after performing a de novo classification decision, rather than in advance as the FDA has proposed in some cases. (RELATED: Experts Question FDA Proposal to Conduct Manufacturing Inspections for de novo Comments, Regulatory guidance March 7, 2019)

Those who oppose the conduct of inspections by the FDA prior to a de novo decision argued that the FDA does not have the legal authority to do so and that such inspections would disrupt the timely review of de novo submissions and impose additional burdens on products that seek to be classified as low to moderate risk products.

Instead, in its final rule, the FDA clarified that it would conduct facility inspections before making a de novo decision when there are data integrity or data quality issues and when there are new or critical manufacturing processes that may impact the safety and efficiency of the devices. “Based on past experience, inspections under these circumstances should take place with a small percentage of de novo requests, ”the FDA said.

In addition, the FDA revised some terms in the section of the rule detailing the data and information to be submitted in a de novo request. Some commentators have challenged the FDA’s requirement that applicants submit all “known or reasonably known” information relating to the device. “In response to these comments, the FDA is revising [the final rule] to clarify that the information required is that known or that should reasonably be known to the applicant, ”writes the FDA. The agency further explains that “the intention to require a de novo request to include information that is known or reasonably known to the applicant is to ensure that the applicant makes a reasonable effort to provide relevant information and does not omit information important to the FDA’s decision to grant or refuse the de novo request due to a failure to conduct reasonable searches for such information.

The FDA has also revised the final rule in response to comments received, “primarily for clarity and accuracy and to reduce the burden of meeting regulatory requirements,” and has made technical revisions throughout for clarity. better clarity. The agency 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 Law on Food, Drugs and Cosmetics (FD&C Act) to regulatory history information that must be submitted in a de novo request. The FDA notes that the latter change was included in the preamble of the proposed rule but was “inadvertently omitted from the proposed regulatory text.”

Along with the publication of the final rule, the FDA revised several of its guidelines for de novo classification to reflect the final rule taking effect in 90 days. The FDA notes that references to 21 CFR Part 860 found in the guidelines are not in effect until the effective date of the final rule. These guidelines include FDA and Industry Actions on De novo Classification Requests: Effect on FDA Clock and Review Targets, De novo classification process (evaluation of automatic class III designation), Usage fees and refunds for De Novo classification requests, and Acceptance exam for de novo classification requests.


© 2021 Society of Regulatory Affairs Professionals.

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