Guidance for Industry: New Contrast Imaging Indication Considerations for Devices and Approved Drug and Biological Products

摘要

FDA intends for the principles in this guidance to promote timely and effective premarket review of, and to promote consistent, appropriate regulation and labeling for imaging drugs and devices. These principles are intended to: (1) promote consistency in the type of scientific or technical information submitted to establish a new imaging contrast indication for use regardless of the type of marketing submission, and (2) to promote compatibility in labeling indication statements.