Grapefruit USA Inc (GPFT)

[King Shaka]

1. Imaging device submission: When a new imaging device or device modification enables an approved imaging drug (i.e., at its approved formulation, dose, dosing regimen, rate, and route of administration) to be used for a new imaging contrast indication in a manner that is consistent with its approved indication, in most cases, FDA expects that a device submission from the device application holder alone would be sufficient to add the new imaging contrast indication to the device. The device submission would be either an original device application for a new device or supplemental device application for a modified device. Through this process, the imaging device developer would add the modified imaging contrast indication to the device labeling without the need for a change to the imaging drug labeling. For example, when new device software allows for the enhancement of the sensitivity and specificity of the same imaging site already identified in the approved imaging drug labeling, and the drug is administered in accordance with its approved labeling and the labeling does not need revision to ensure safety and effectiveness, the Agency believes in most instances a device submission and device labeling change alone should suffice.