Heart valve allograft litigation
This article was originally published in The Gray Sheet
Remanded to the U.S. District Court for the Northern District of Illinois in a July 27 opinion of the Seventh Circuit Court of Appeals. At issue is whether FDA "promulgated a back door amendment" to replacement heart valve regulations, thereby denying the plaintiffs, Northwest Tissue Center and Oregon Tissue Bank, "the right to notice and comment on the regulation of allografts." In 1991, the agency issued a notice of applicability of a final rule (NAFR) stating that heart valve allografts are subject to replacement heart valve regs, including a 1987 call for premarket approval applications for the devices. Previously, according to the tissue banks, FDA indicated that despite its "authority over processors of human source valves," it would not exercise that authority. The appeals court upheld the district court's dismissal of two other issues in the litigation ("The Gray Sheet" Nov. 16, In Brief).
You may also be interested in...
A combined final opinion on the European Chemicals Agency’s proposed microplastic restriction is expected from ECHA committees by year-end, at which point the European Commission will consider whether and when microplastic must be removed from all leave-on cosmetic products marketed in the EU.
Butterfly Network’s CEO Laurent Faracci outlines the company’s growth strategy and plans for their “ultrasound-on-a-chip” technology after its merger with blank check company Longview Acquisition Corp. See what the company’s CEO said about it here.
CDC’s Advisory Committee on Immunization Practices votes 13-1 that these two groups be first in line for vaccination once FDA authorizes a vaccine and ACIP recommends it. Goal of vote is to guide health departments in placing vaccine orders.