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Experts Question FDA Proposal to Conduct Manufacturing Inspections for De Novo Reviews

Posted 07 March 2019 | By Ana Mulero 

Experts Question FDA Proposal to Conduct Manufacturing Inspections for De Novo Reviews

Industry experts raised questions around the US Food and Drug Administration (FDA) recent proposal that would allow FDA to inspect manufacturing facilities prior to granting de novo classification requests.

The proposal is part of the 76-page proposed rule FDA’s Center for Devices and Radiological Health (CDRH) set forth last December. The proposed rule addresses the lack of de novo-specific regulation that puts the program at a disadvantage compared to the traditional 510(k) clearance and the premarket approval application (PMA) pathways, CDRH de novo program director Sergio de del Castillo recently noted. Yet comments submitted on the proposed rule argued that it mirrors regulatory requirements of the more burdensome PMA pathway versus that of 510(k)s.

The comment period on the de novo proposed rule closed on Thursday, with submissions from AdvaMed and Cook Medical, among others. The shared argument against allowing FDA to conduct manufacturing site visits as part of the review process of de novo classification request calls into question the agency’s authority for a granted request to be contingent on quality system compliance.

Bradley Merrill Thompson, an attorney at Washington-based law firm Epstein Becker Green, sought to build on a review of the inspection component of de novo proposed rule in a December 2018 blog post from the law firm Hyman Phelps & McNamara.

“The blog post politely predicts that this particular provision of the proposed rule will be controversial,” Thompson said. “I would like to explain why, in fact, the provision is unlawful.” He cited the Fourth Amendment and section 704 of the FD&C Act to argue FDA “has no inherent legal right” for pre-classification visits.

Similarly, AdvaMed vice president of technology and regulatory affairs Steve Silverman pointed to a lack of authority under the FD&C Act to conduct an inspection as a prerequisite to granting a de novo.

Cook Medical echoed Thompson and Silverman’s arguments against pre-classification inspections. The arguments are centered on how FDA has the authority to subject class III devices to pre-approval inspections, but not class I or class II devices. Yet the proposal to allow for pre-classification inspections as part of de novo reviews does not stray far from the authority the agency has for pre-approval inspections. This is because any device type for which a manufacturer seeks a new classification via a de novo request is automatically classified into class III. The agency also has the authority to inspect facilities that are manufacturing products that meet the definition of a medical device without FDA approval, regardless of whether a premarket submission is pending review.

The proposal does not set quality system noncompliance as the grounds for denying a de novo classification request, though denying an inspection would result in a submitted de novo request to be considered by the agency as withdrawn. Commenters argued this contradicts the purpose of the de novo process, which is to minimize burden and unnecessary expenditure of FDA and industry resources.

Disruption of timely FDA de novo reviews, increased regulatory burden on manufacturing operations and stifled innovation are at least some of the unintended consequences that can come as a result of the inspection proposal in the de novo proposed rule, according to the commenters. Commenters offered potential solutions to avoid unintended consequences. These include alignment with the statutory requirement for inspection class II sites prior to 510(k) clearances and requiring that sufficient information for demonstrating quality system compliance be submitted as part of a de novo request.


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