WHAT: Total prohibition on the current and future sales, distribution, and manufacturing of a medical device

WHY:  Analyzing and weighing the risks and benefits the device poses to individuals. Can ban a device without actual proof of illness or injury, and only needs to find that a device has the potential to present the required degree of risk based on all available data and information

WHEN: Acts on this authority very rarely. Until 2016, the FDA banned only one other medical device, prosthetic hair fibers. In 2016, FDA proposed ban on powdered gloves on the unreasonable and substantial risk of illness or injury to exposed individuals

HOW: Notice of proposed rulemaking is published in the Federal Register



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