Apr 17
Fresenius Kabi USA, LLC Recalls Ivenix Infusion Pump LVP Software for Anomalies That Have the Potential to Cause Serious Patient Harm or Death
Medical Devices
FDA Commissioner Dr. Robert M. Califf discusses nutrition and offers a peek at some new packaging label prototypes.
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Health professionals, consumers and patients can voluntarily report observed or suspected adverse events for human medical products to FDA. Voluntary reporting can help FDA identify unknown risk for approved medical products.
Learn MoreApr 17
Medical Devices
Apr 17
Medical Devices, Radiation-Emitting Products
Apr 17
Medical Devices
I recently had the privilege of official travel to the U.K. and European Union with our global affairs team.
At the FDA, we’ve been working for years to anticipate and prepare for the challenges of Artificial Intelligence (AI), and also to harness its potential.
FDA and the Office for Human Research Protections have published a draft guidance: “Key Information and Facilitating Understanding in Informed Consent.”
FDA MedWatch Safety Information
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