New Contrast Imaging Indication Considerations for Devices and Approved Drug and Biological Products
FDA intends this guidance to assist developers of medical imaging devices and imaging drug/biological products (hereinafter more generally referred to as drugs or drug products) that provide image contrast enhancement in determining:
- When the imaging device developer may add certain new imaging contrast indications to its device for use with already approved imaging drugs without a need for a modification of the drug labeling;
- When the imaging drug developer may add certain new imaging contrast indications to its drug for use with already approved imaging devices without a need for a modification of the device labeling, and
- What type of marketing submission(s) the imaging drug or imaging device developer should submit to FDA to request approval/clearance to add a new imaging contrast indication.
Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)
If unable to submit comments online, please mail written comments to:
Division of Dockets Management (HFA- 305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852
All comments should be identified with the title of the guidance.