US FDA informs Cytori Therapeutics that the Celution 700 System will be regulated as a medical device under the Federal Food, Drug, and Cosmetic Act. This determination was in response to the company's Request for Designation, clears the way for the company to file and submit a marketing application to the US FDA for the Celution 700 System for use as a medical device in aesthetic body contouring and/or filling of soft tissue voids.
This important decision provides greater clarity of our regulatory path in the US and is consistent with our interpretation of current device regulations, said Christopher J. Calhoun, chief executive officer for Cytori. We are preparing for the next steps in the process of working with the FDA to determine the specific device marketing application to submit, including whether clinical evaluations will be necessary.
Based on the jurisdictional determination from the US FDA, Celution 700 device marketing applications will be reviewed by the FDA’s Center for Biologics Evaluation and Research under the law applicable to medical devices. If required clinical investigations would be conducted in accordance with the Investigational Device Exemption (IDE) regulations but not the Investigational New Drug regulations which is applicable to drugs and biologics.