MBI Optison ultrasound contrast agent review to shift to CDER under FDA classification ruling.

Executive Summary

MBI OPTISON ULTRASOUND CONTRAST AGENT REVIEW SHIFTED TO CDER with a user fee deadline of Oct. 17, FDA indicated in a July 29 decision clarifying that ultrasound contrast agents are classified as drugs, not medical devices. Molecular Biosystems, Inc. submitted a PMA device application to the Center for Devices & Radiologic Health for Optison (FS069) on Oct. 17, 1996. That application will be transferred to the Center for Drug Evaluation & Research. MBI must pay a user fee, and the PMA filing date will serve as the determination of the user fee deadline, FDA said.