FDA draft guidance targets timely regulation, labeling for imaging drugs, devices
The FDA is seeking public comment on a draft guidance for medical imaging devices with contrast agents or radiopharmaceuticals that focuses on developing new contrast indications for imaging device use with already approved imaging products.
The guidance, "New Contrast Imaging Indication Considerations for Devices and Approved Drug and Biological Products,” was issued as part of the Medical Device User Fee Amendments of 2007 (MDUFA) Commitment for the Performance Goals and Procedures, to assist developers of medical imaging devices and imaging drug/biological products that provide image contrast enhancement, according to a Oct. 7 notice in the Federal Register.
The recommendations in the guidance are intended to promote timely and effective review of, and consistent and appropriate regulation and labeling for, imaging drugs and devices, the agency said. Public comments on the draft guidance can be submitted until Jan. 5, 2009.
The guidance, "New Contrast Imaging Indication Considerations for Devices and Approved Drug and Biological Products,” was issued as part of the Medical Device User Fee Amendments of 2007 (MDUFA) Commitment for the Performance Goals and Procedures, to assist developers of medical imaging devices and imaging drug/biological products that provide image contrast enhancement, according to a Oct. 7 notice in the Federal Register.
The recommendations in the guidance are intended to promote timely and effective review of, and consistent and appropriate regulation and labeling for, imaging drugs and devices, the agency said. Public comments on the draft guidance can be submitted until Jan. 5, 2009.