Listen to the podcast via the player below:
Medtech Insight articles addressing topics discussed in this episode:
Welcome to Medtech Insight
Create an account to read this article
Already a subscriber?
Device Week, 20 December 2019 – Device Tax Repeal, US FDA Funds, LAB Act And More In Latest Budget
In this edition of Device Week, Medtech Insight senior reporters Ferdous Al-Faruque and Sue Darcey discuss a new spending bill approved by the US House and Senate that repeals the medical device excise tax, adds new funds for the US FDA and passes the LAB Act.
More from Legislation
• By
Paul Campbell, chief regulatory officer at HealthAI, emphasizes existing regulations for AI in healthcare should not be overlooked as new regulations are developed.
• By
The US FDA needs to know who wants a seat at the MDUFA negotiations table before discussions can begin. The agency is asking stakeholders to let it know if they plan to participate in the periodic consultation meetings before July 28.
• By
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.
• By
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.
More from Policy & Regulation
• By
The last steps are taking place leading to the launch of the EU’s medical device database, EUDAMED.
• By
Researchers at Johns Hopkins have used a robotic system to autonomously perform a key part of gallbladder surgery without a surgeon's hand. Lead author Axel Krieger says it could take five to 10 years before an autonomous robotic system will reach human trials and expects regulatory hurdles.
• By
“RRAs are valuable oversight tools and under certain circumstances, can assist FDA in its mission to protect public health, oversee regulated industry, and help ensure regulated products comply with FDA requirements,” according to final guidance.