The task force will help in solving the problems in the approval or registration of stakeholders for medical devices. The FDA will now be able to make the classifications based on the Asean ...

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.