government

Evidence page

Regenerative Medicine Advanced Therapy Designation

U.S. Food and Drug Administration

Published Nov 4, 2025accessed Sep 18, 2026Updated Sep 19, 2026

Original source

https://www.fda.gov/vaccines-blood-biologics/cellular-gene-therapy-products/regenerative-medicine-advanced-therapy-designation

fda.gov

Verification

Verification	Not yet verified
Evidence level	—
Source	government
Link status	Reachable at last check

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Cited by (2)

FactRegenerative Medicine: U.S. legal definition (RMAT) = A cell therapy, therapeutic tissue engineering product, human cell and tissue product, or any combination of these; certain human gene therapies and xenogeneic cell products may also qualify (FD&C Act section 506(g))FactRegenerative Medicine: RMAT designation criteria = Must be a regenerative medicine therapy intended for a serious or life-threatening condition, with preliminary clinical evidence of potential to address unmet medical needs (21st Century Cures Act section 3033)