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The FDA has deemed Fresenius Kabi’s March 8 recall of its Ivenix Infusion System as Class I, the most serious type of recall, as use of the device may cause serious injuries or death. Read More
The FDA would like to have the regulatory authority to restrict new opioid approvals to those that are safer than already-approved and marketed opioids, Commissioner Robert Califf told senators at a hearing discussing the agency’s 2024 budget request. Read More
The FDA has slapped Abbott Point of Care Canada with a warning letter for marketing a product with design and component changes without applying to the agency for clearance or approval. Read More
Upcoming events in the coming weeks include six FDA advisory committee meetings as well as webinars and conferences on subjects ranging from medical device enforcement, real-world evidence and root cause analysis. Read More
The top citations in FDA warning letters tend not to change radically from one year to the next, but the agency’s warning letters for fiscal 2022 hint at an increased focus on component testing and contractor oversight. Read More
Wirelessly connected infusion pumps, nurse call systems and medication dispensing systems are highly vulnerable to malicious activity, according to new research by security company Armis.
There are several “green” pathways to help expedite overseas medical device and in vitro diagnostics (IVD) approval in China — including the innovation, priority and emergency use pathways, as well as special zone policies. Read More
The replacements come from the June 2021 recall of certain ventilators, bilevel positive airway pressure machines, and continuous positive airway pressure machines. Read More