FDA Finalizes Guidance on Imaging Indications

The FDA has issued a final guidance detailing when manufacturers of imaging equipment can avoid changing their product labeling when drugmakers add new indications to associated imaging drugs or biologics. If a new imaging device or device modification would use an approved drug for a new contrast indication consistent with its labeling, the FDA expects only the devicemaker would need to submit an original or supplemental device application, as appropriate, to add the new imaging contrast indication to the device, the guidance says.
Devices & Diagnostics Letter