Simple Radiologic Devices

Simple radiologic device (SRD) placement of an unshielded, high-level radioactive substance in a public place... 

Because terrorists are unlikely to announce an attack with a simple radiological device or a ROD, there may be no warning that contaminated patients are arriving at an... 

A nuclear terrorist incident can involve the detonation or threatened detonation of a nuclear bomb or the detonation or threatened detonation of an explosive device that includes nuclear materials. Terrorists could also cause a nuclear incident by detonating an explosive device near a nuclear power plant or attacking nuclear cargo during transport. Terrorists could contaminate food or other products with radioactive materials. Simple radiological devices such as an isotope, if placed in public, could spread radiation without the use of an explosive device. 

Once a Sponsor determines that their product fits one of the definitions of a combination product, the sponsor then must determine the lead Center within the FDA that will assume regulatory responsibility for the product. This determination is made by considering the primary mode of action (PMOA) [4] of the product. In simple terms, if the main function of the product is a device function, then it is likely that the Center for Devices and Radiological Health (CDRH) will have primary responsibility for the product. On the other hand, either the Center for Biologies Evaluation (CBER) or the Center for Drug Evaluation and Research (CDER) will be assigned primary review responsibility based on whether the PMOA of the product is dependent on... 

Curr Opin Pediatr 17 690-694 Poznanski A (1969) A simple device for administering barium to infants. Radiology 93 1106 Quan L, Smith WL (1973) The VATER association vertebral defects, anal atresia, T-E fistula with esophageal atresia, radial and renal dysplasia a spectrum of associated defects. J Pediatr 82 104-107... 

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