USA – FDA Proposes Rule to Implement New De Novo Classification Process

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 firsdiscussed 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. These 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…