Bradley Merrill Thompson Quoted in “Experts Question FDA Proposal to Conduct Manufacturing Inspections for De Novo Reviews”

RAPS Regulatory Focus

Bradley Merrill Thompson, Member of the Firm in the Health Care & Life Sciences practice, in the firm’s Washington, DC, office, was quoted in RAPS Regulatory Focus, in “Experts Question FDA Proposal to Conduct Manufacturing Inspections for De Novo Reviews,” by Ana Mulero.

Following is an excerpt:

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 propose 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 Actto argue FDA “has no inherent legal right” for pre-classification visits.