FDA Proposes Rule to Implement New De Novo Classification Process

Regulatory NewsRegulatory News | 04 December 2018 |  By 

The US Food and Drug Administration (FDA) issued a proposed rule on Tuesday to establish requirements on the de novo review pathway for classifying new medical device types.

If finalized, the rule will implement the de novo classification process and define the scope of regulatory procedures used by agency staff and classification panels convened by FDA when classifying and reclassifying medical devices.

The work at FDA’s Center for Devices and Radiological Health (CDRH) to issue the new proposed rule was first discussed in October at RAPS’ 2018 Convergence. The current lack of a de novo-specific regulation puts the de novo program at “somewhat of a disadvantage” compared to the 510(k) and premarket application (PMA) review pathways, CDRH’s Sergio de del Castillo said.

General Provisions

The 76-page proposed rule sets forth the procedures and criteria for manufacturers to follow when developing requests for new device classifications via the de novo program. In addition to this voluntary process for a firm to both submit and withdraw a de novo classification request, other provisions in the proposed rule clarify how agency staff intend to accept, review, grant and/or decline a de novo request.

The rule proposes to allow for a firm to submit a de no classification request with or without first receiving a not substantially equivalent determination on a 510(k). The agency “may refuse to accept a de novo request that is ineligible or is incomplete on its face” under the proposed rule, which would also give agency staff more leeway in refusing to accept determinations on requests deemed inadequate.

The proposal 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. The newly proposed de novo requirements are intended to “limit the unnecessary expenditure of FDA and industry resources” when evaluating a PMA application for a proposed device that is better suited to undergo a 510(k) review, the agency said.

Codified Requests

FDA finalized guidance in 2017 to offer recommendations on obtaining feedback regarding content for de novo requests, among other aspects of the program. Yet “some de novo requests lack crucial data or other information rendering the requests incomplete and requiring additional reviews,” the agency said.

The proposal involves codifying the minimum requirements on content to include in a de novo classification request through the addition of a new subpart D to 21 CFR part 860.

The content requirements under the proposed rule seek to help applicants anticipate FDA’s expectations by providing regulatory clarity and predictability. These include a table of contents, information to contact the de novo requester, a statement on the device’s regulatory history and a summary of each study used in support of a de novo request, among several other requirements.

Many of the proposed content requirements relate to the results of any clinical investigation that involved human subjects, including those conducted overseas, to support a de novo request. The rule proposes to include various elements in this section, including a discussion of observed device failures.

‘Banner Year’

Last year was a “banner year” for the de novo program, with the average number of granted de novo classification requests totaling nearly 100 in 2017 versus just 22 during 2012, said de del Castillo. The newly proposed rule was partly driven by this anomaly as FDA aims to provide greater consistency in anticipation of an expected growth in use of the de novo regulatory review pathway, he added.

All other regulatory review pathways for medical devices in the US have been subject to new policy proposals this year in addition to the de novo pathway, including an overhaul announced last week of the pathway used for most devices to obtain FDA marketing clearance via 510(k)s.

According to FDA Commissioner Scott Gottlieb, the agency believes the new 510(k) policy proposals will result in more devices using the de novo pathway than previously anticipated. This is because the 10-year limit on the use of predicate devices under the new 510(k) framework would lead to more firms looking to establish a new classification in absence of an existing device. A larger pool of granted de novo classification requests would also result in a spike in the number of 510(k) submissions.

The de novo proposed rule is intended to provide “clear standards, expectations and processes” for de novo classification requests “as a way to continue to modernize the 510(k) process,” Gottlieb said.



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