Cell and tissue combo devices
This article was originally published in The Gray Sheet
CDRH will take the lead in reviewing human cell sorters for in vitro diagnostics, while the Center for Biologics Evaluation and Research has jurisdiction over devices that process cells or tissue for therapeutic readministration, according to a July 1jurisdictional update from FDA's Office of Combination Products. Products in the latter category include devices that isolate and concentrate a patient's stem cells before reinjection, as well as devices that process autologous blood or tissue to produce tissue engineered therapies (2"The Gray Sheet" March 5, 2007, p. 14)...
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