Landmark FDA Move: First Quality Control Protocol for Mesenchymal Stromal Cells (MSCs) Sets New Therapeutic Standard

FDA Device Master File Information

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TIANJIN, China, Jan. 25, 2026 /PRNewswire/ -- In a landmark move for the cell therapy industry, a Device Master File (DMF) describing the first dedicated quality control standard for Mesenchymal Stromal Cells (MSCs) was accepted by the U.S. Food and Drug Administration (FDA). The agency's Master File acknowledgement letter, issued on January 9, 2026, incorporates the "Tasly 3P Characterization of MSCs Assay" (MF 32345) into its regulatory framework. This step provides long-sought guidance to ensure the consistent, safe, and effective clinical use of MSCs.

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