On this week's podcast, Medtech Insight's David Filmore and Ferdous Al-Faruque discuss the recently enacted FDA Reauthorization Act. It comes with higher industry fees, but also a host of US FDA commitments and reforms. The legislation was broadly supported by lawmakers and industry alike, but President Trump? Not so much.
Listen to the podcast via the player below:
Medtech Insight articles addressing topics discussed in this episode:
Join thousands of industry professionals who rely on Medtech Insight for daily insights
Already a subscriber?
The US FDA has given up on its effort to regulate lab-developed tests as medical devices, at least for now. The agency will not appeal a decision from the Eastern District of Texas that tossed out the FDA’s final rule, leaving the agency with few cards.
During MD&M East in Manhattan last week, a panel of experts discussed how the Trump administration’s trade policy is affecting manufacturing and offered some ideas on what manufacturers can do to help mitigate the chaos.
A battle may be forming over the 2027 FDA user fee reauthorizations. At a conference Friday, Democratic Rep. Jake Auchincloss supports them for their effectiveness, while Deputy FDA Commissioner Grace Graham echoed criticisms from HHS Sec. Kennedy, among others, in calling for reform to ensure public trust.
Health and Human Services Secretary Robert F. Kennedy Jr. emphasized administrative cost reductions and defended budget decisions during a Senate hearing on HHS funding. Some senators, however, expressed concerns over the impacts spending cuts had on essential health programs.
Overlapping clinical testing requirements and decision-making around significant changes to MDAI are among the tricky subjects that the new document explains.
FDA officials Michelle Tarver and Marty Makary discussed advancements in home healthcare during a podcast. They highlighted the importance of continuous glucose monitors, emphasized home healthcare's benefits for chronic diseases, and mentioned the agency's efforts to streamline device development.
The UK's regulatory agency is the first to join a new international network for oversight of AI in healthcare run by a non-profit organization, HealthAI, the global agency for responsible AI in health.
