User Fee Bill Clarifies FDA Can Ban Devices For One Or More Uses

By Kelly Lienhard / May 6, 2022 at 3:08 PM
House lawmakers’ recently unveiled user fee legislation aims to clarify that FDA has authority to ban a medical device for one or more intended uses, and it goes so far as to specifically ban the use of electric shock devices to treat patients with aggressive or self-harming behaviors, coming nearly one year after a federal appeals court overruled FDA’s authority to issue a use-specific ban on electrical stimulation devices (ESDs). Regulatory lawyers had said the federal court’s ruling could further...

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