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Makers of connected medical devices should brace themselves for more FDA enforcement — warning letters, inspections, demands for information and untitled letters — as the digital health space unfolds and evolves, says a former Justice Department prosecutor. Read More
The FDA has deemed Avanos Medical’s Feb. 22 recall of certain Ballard Access closed suction ventilation devices as Class I, the most serious type of recall, as using these devices may cause serious injury or death. Read More
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
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
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
New final guidances from the International Medical Device Regulators Forum (IMDRF) explain how to identify and address cybersecurity risks in older devices containing software and offer advice on large-scale manufacturing and validation of personalized devices. Read More
A new final guidance advises devicemakers to include 11 categories of information in 510(k) submissions for catheter-based devices to treat peripheral vasculature lesions, including detailed device description, components and mode of operation, comparison with the predicate devices and other details. Read More
The FDA has laid out its current thinking on the adhesive performance and irritation potential of generic transdermal and topical drug delivery systems and clarified recommendations for designing safety and efficacy studies for these products, in a pair of revised draft guidances. Read More
Multiple devices and digital behavioral interventions have been approved or are in the works to help patients suffering from opioid use disorder (OUD), says FDA Commissioner Robert Califf, but obstacles such as a high failure rate and proof of efficacy stand in the way of wider adoption. Read More