The drug regulator has sought the industry to submit their comments ... as Class A comprising low risk devices, Class B for low moderate risk devices, Class C for moderate high risk products, and ...

Here are three recent recalls reported to the FDA: ...

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, ...

Discover the latest FDA-cleared orthopedic and spine devices and technologies, including robotics, implants, and bone graft systems.