Becker's Hospital Review4d
3 medical device recalls
Here are three recent recalls reported to the FDA: ...
PharmiWeb1d
De Novo Request Helps Bring Low and Medium Risk Devices to Market
De Novo is an approach for the FDA to classify novel medical devices based on risk for devices whose safety and effectiveness can be ensured through general controls or specific controls (i.e., low ...
JD Supra6d
FDA Issues Draft Guidance Documents on Artificial Intelligence for Medical Devices, Drugs, and Biological Products
FDA recently issued two draft guidance documents discussing: (1) the use of artificial intelligence (AI) to produce information to support ...
JD Supra7d
FDA’s evolving regulatory framework for AI use in drug & device clinical trials and research
Commissioner Robert Califf, M.D., and other senior FDA officials recently published a “Special Communication” in JAMA describing FDA’s concerns with the use of AI in medical product development, ...
Becker's Spine Review4d
7 spine, orthopedic devices earning FDA clearance in 1 month
Discover the latest FDA-cleared orthopedic and spine devices and technologies, including robotics, implants, and bone graft systems.