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An overview of the FDA regulatory framework governing regenerative medicine is provided. The chapter distinguishes between Class 351 and Class 361 products under 21 CFR Part 1271 and discusses implications for clinical use and physician oversight.

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Regulatory Considerations in Regenerative Medicine

  • 章节

  • 发表日期：

    2026年

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  • Ripu D. Arora

摘要

An overview of the FDA regulatory framework governing regenerative medicine is provided. The chapter distinguishes between Class 351 and Class 361 products under 21 CFR Part 1271 and discusses implications for clinical use and physician oversight.