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FDA Reviewing Information Collection on Medical Devices

Tuesday, April 12, 2016
Sandler, Travis & Rosenberg Trade Report

The Food and Drug Administration is accepting through May 11 comments on the proposed extension of an information collection regarding administrative detention and banned medical devices.

FDA has the statutory authority to detain during established inspections devices that are believed to be adulterated or misbranded. Under FDA regulations, an applicant of a detention order must show documentation of ownership if devices are detained at a place other than that of the appellant. In addition, the owner or other responsible person must supply records about how the devices may have become adulterated or misbranded as well as records of distribution of the detained devices.

FDA also has the authority to ban devices that present substantial deception or an unreasonable and substantial risk of illness or injury. Under FDA regulations, a manufacturer, distributor or importer of a device may be required to submit all relevant and available data and information to enable the FDA to determine whether the device presents substantial deception, unreasonable and substantial risk of illness or injury, or unreasonable, direct and substantial danger to the health of individuals.

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