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The U.S. FDA Released Guidance Documents on Evaluation of Devices Used in Regenerative Medicine

On November 16, 2017, the U.S. Food and Drug Administration released several guidance documents to provide sponsors and device manufacturers engaged in the development of regenerative medicine products, including novel cellular therapies, with the Agency's current thinking regarding evaluation of devices use in the recovery, isolation or delivery of regenerative medicines advanced therapies (RMAT).

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