D.C. Circuit Upholds FDA's Premarket Requirement For Fat / Stem Cell Devices

WASHINGTON, D.C. - The Food and Drug Administration did not act in an arbitrary or capricious manner when it determined that two medical devices intended to extract stem cells from human fat must go through the premarket approval (PMA) process, a federal appeals court ruled March 22 in affirming the agency's decision (Cytori Therapeutics, Inc. v. Food & Drug Administration, No. 11-1268, D.C. Cir.)....(read more)