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The FDA finalized guidance on medical product communications that are consistent with FDA-required labeling, presenting a three factor test to determine whether a communication is consistent with labeling requirements. Read More
The new requirements address labeling, shelf life and temperature requirements as well as general requirements for registering devices and IVDs in Saudi Arabia. Read More
The device is for use in radiology practices, hospital radiology departments and other disciplines that rely on medical imaging for diagnosis and therapy. Read More
The Ensuring Patient Access to Critical Breakthrough Products Act (H.R. 5997) would require Medicare to cover all breakthrough products that are approved through the FDA’s expedited review process for three years. Read More