WASHINGTON - A federal appeals court is siding with the Food and Drug Administration in a case brought by medical device maker Cytori, ruling that the agency was correct to reject fast-track approval for two company devices used to process adult stem cells.
Cytori makes the Celution and StemSource devices which separate adult stem cells from fat tissue using a combination of spinning motions and chemical reactions. The company asked the FDA to approve the devices using a fast-track pathway reserved for devices that are similar to products already on the market. Cytori argued that its devices are similar to devices used to process blood and bone marrow.
A three-judge panel said the FDA was right to reject that argument and to require the company to apply through a more rigorous process.