House user fee bill includes postmarket provisions
This article was originally published in The Silver Sheet
Executive Summary
Passed July 11, H.R. 2900 would allow FDA to collect $287 million in fees from device manufacturers over the next five years, and would commit the agency to meeting new premarket review performance goals. In addition, the bill authorizes $7.1 million a year in Congressional appropriations to help FDA collect, develop, review and evaluate postmarket safety information on medical devices. Other provisions would establish a unique device identification system; require a Government Accountability Office report on the prevalence and causes of hospital-acquired infections attributable to medical devices; require a GAO report on the "appropriate use" of the 510(k) premarket notification process; and clarify that a company can market a device while not carrying out FDA postmarket surveillance orders when the validity of the order is under formal FDA review at the company's request. The bill must now be reconciled with the Senate version (S. 1082), passed May 9. FDA Commissioner Andrew von Eschenbach urged Congress to approve a final, reconciled bill "as early in September as possible." The current user fee program expires Sept. 30
You may also be interested in...
New EU Approvals
The Pink Sheet's list of EU centralized approvals of new active substances has been updated to add two new products, including Ryzneuta, Evive Biotechnology's treatment for chemotherapy-induced neutropenia.
Pair Of Deaths Linked To Recalled Vyaire Medical Respiratory Devices
The US FDA has labelled a recall of more than 6 million Airlife respiratory support devices class I. The recall covers devices manufactured in 2017 or earlier that can fail to provide adequate ventilation.
Over The Counter 2 Apr 2024: Analyzing The Spin-Out Trend In Consumer Health, With HBW’s Malcolm Spicer And Tom Gallen
In this episode, HBW Insight’s Europe and US editors bring their expertise to bear on the current the trend towards standalone OTC companies in global consumer health. We look at four major players: Haleon, which separated from GSK almost two years ago; Kenvue, soon to celebrate its first anniversary as a new company; Sanofi Consumer Healthcare, which is poised to split from its pharma parent; and Bayer, which has decided to buck the trend, holding on to its consumer health division. We discuss some of the advantages of becoming a standalone company, for example in leaning into a wider concept of self-care.