FDA Sounds Alarm: Cluster Of Class I Recalls Prompts Aluminum Toxicity Warning From Agency
The US agency has warned health care providers that certain devices used to warm fluids for bodily circulation could leach dangerous levels of aluminum.
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Thousands of procedure packs made by DeRoyal Industries Inc. are being recalled because they include a NORMOFLO Irrigation Warming Set that was the subject of a recent high-risk class I recall by manufacturer Smiths Medical because the device may leach aluminum.
In this FINAL EPISODE of Speaking Of Medtech: The US FDA got something it desperately wanted in its latest user-fee package with industry: a Total Product Lifecycle Advisory Program pilot, or TAP. The agency says TAP will allow for earlier and more frequent engagement with developers – but is it needed?
People with obesity now have new tools to help them lose weight, thanks to the US agency’s de novo authorization.