Cell and Gene therapy products

Articles containing or consisting of human cells or tissues that are intended for implantation, transplantation, infusion, or transfer to a human  recipient. Gene therapies are novel and complex products that can offer unique challenges in product development. Hence, ongoing communication between the FDA and stakeholders is essential to meet these challenges. Gene therapy products are being developed around the world, the FDA is engaged in a number of international harmonization activities in this area.

Examples: Musculoskeletal tissue, skin, ocular tissue, human heart valves; vascular graft, Dura mater, reproductive tissue/cells, Stem/progenitor cells ,somatic cells, Cells transduced with gene therapy vectors , Combination products (e.g., cells or tissue + device)

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