Despite being a factor in lawmaker discussions throughout the shutdown, provisions to delay or repeal the device tax did not survive in the final agreement to reopen the federal government and raise the debt ceiling. But the issue appeared to gain more momentum than ever that companies hope can be maintained into upcoming budget conference talks.
Device tax repeal or delay seemed to be a constant topic of discussion by lawmakers, journalists and White House officials throughout the two-week government shutdown, but the matter was not addressed in the final deal signed by the president in the early morning of Oct. 17.
The legislation, which funds federal agencies under a continuing resolution through Jan. 15 and raises the federal debt ceiling through...
The US House of Representatives passes legislation requiring manufacturers of non-flushable wet wipes to label products as ‘non-flushable," a move endorsed by the Personal Care Products Council.
Paul Campbell, chief regulatory officer at HealthAI, emphasizes existing regulations for AI in healthcare should not be overlooked as new regulations are developed.
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.
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.
A recent JAMA column called for the US FDA to create an online database of medical device labeling, arguing that the move would increase transparency and help researchers, among other benefits. Medtech Insight discussed the idea with the paper’s lead author.
EU member states have issued a consensus statement on the urgent need to build momentum to tackle governance and centralization issues as part of much-needed reform of the EU medtech regulatory system.
A recent FDA warning letter claims a Boston firm that specializes in wearable technology marketed a blood pressure device without agency approval. The company rejects the assertion and says the agency is out of step with federal law.
