The U.S. FDA has followed up on reports of problematic syringes made by several companies in mainland China, recommending that U.S. suppliers, consumers and health care organizations stop using these products unless no alternatives are available. The agency said it has issued warning letters to three of these companies, at least one of which appears to have been the supplier of Monoject syringes that have been the subjects of recent FDA recalls.
The U.S. FDA is holding a series of town halls on the use of sterilization methods as alternatives to ethylene oxide (EtO) in response to other federal agency rulemaking, and some of these changes in sterilization methods will not require a new regulatory filing.
The U.K. National Institute for Health and Care Excellence (NICE) has released a preliminary health technology assessment for three modules of the Proknow series of software systems by Stockholm-based Elekta AB, which may improve the delivery of radiotherapy services across the U.K. However, NICE indicated it wants to see more evidence regarding the impact of these software modules on radiotherapy treatment plans.
The U.S. FDA posted two warning letters to device makers in the second week of March 2024, one each to Exactech Inc., of Gainesville, Fla., and the other to Nobles Medical Technology II Inc., of Fountain Valley, Calif. The themes of these warnings are entirely different, with Noble receiving a warning regarding clinical trial oversight and Exactech taking a hit for routine good manufacturing compliance issues, showing that the FDA is active in the post-COVID compliance realm.
The U.S. Environmental Protection Agency (EPA) has issued its long-awaited final rule governing emissions of ethylene oxide (EtO), a rule announced by the agency with the concurrence of Xavier Becerra, the Secretary of Health and Human Services. However, the final rule provoked an immediate response from Sen. Bill Cassidy (R-La.), who said the final rule will “put American lives in danger.”
There are coincidences and then there are big coincidences, the latter of which might describe a new U.S. FDA draft guidance and a major cybersecurity breach. The agency has issued a draft update to its premarket cybersecurity guidance even as the Department of Health and Human Services announced an investigation into the hack of the IT system at Change Healthcare, a pair of developments that seem likely to set the world of connected medical devices on its collective ear.
Medicare coverage of medical software in the U.S. is generally not the subject of flattering remarks from industry, but the novelty of the subcategory of artificial intelligence (AI) would seem to suggest that the Medicare problem for AI is even more severe. That suspicion was borne out by consultant Bruce Quinn who said at a public meeting here in Washington that some areas of software coverage and reimbursement, including AI software, “are just a train wreck,” a problem he said is especially acute in fee-for-service care.
The news about how the U.S. False Claims Act (FCA) is adjudicated in the courts is typically dismal, but the U.S. Court of Appeals for the Ninth Circuit recently provided an exception.
The European Parliament (EP) has passed the Artificial Intelligence Act (AI Act), bringing the legislation one step closer to full passage into law, with passage by the European Council the only remaining hurdle.
U.S. deputy attorney general Lisa Monaco recently outlined some new programs related to federal enforcement across the economy, including some novel elements related to artificial intelligence. However, the more important take-away, according to Preston Pugh of Crowell & Moring LLP, is that the Department of Justice (DOJ) continues to work to make the legal environment more friendly to would-be whistleblowers, thus increasing the risk for companies inside and outside the life sciences.
