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Ninth Circuit Confirms: Certain Stem Cell Products Require FDA Premarket Approval

Cooley LLP

Published Oct 31, 2024accessed Sep 18, 2026Updated Sep 19, 2026

Original source

https://www.cooley.com/news/insight/2024/2024-10-31-ninth-circuit-confirms-certain-stem-cell-products-require-fda-premarket-approval

cooley.com

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Evidence level	—
Source	industry
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Cited by (1)

FactAdipose-derived Stem Cell: US court ruling on adipose-derived cell products = Ninth Circuit (US v. California Stem Cell Treatment Center, 2024-09-27): enzymatically processed adipose SVF is not covered by the same-surgical-procedure exception, and the products are drugs that need premarket approval