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Get The FDA Web Page For Information On - Gpo

G Products/RadiationEmittingProductsand Procedures/MedicalImaging/ ucm298899.htm. 10. Under section 513(i)(1)(E)(i) of the Federal Food, Drug, and Cosmetic Act, when determining that a device is substantially equivalent to a predicate device, FDA may require limitations in device labeling about off-label use of the device when there is a reasonable likelihood of such use, and if such use could cause harm. Such determinations are made on a case by case basis and other requ.

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