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Comments Sought on Detained/Banned Devices

04/10/2012

Federal Register Notice: FDA is seeking comments on information collection for administrative detention and banned medical devices. FDA has the statutory authority under FDCA 304(g) to detain during established inspections devices that are believed to be adulterated or misbranded. It also has the statutory authority under section FDCA 360(f) to ban devices that present substantial deception or an unreasonable and substantial risk of illness or injury. Comments should be submitted by 6/11. To view this notice, click here.

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