Regenerative Products FDA Tracker

Exosomes, cell-based products, human-derived ECM and skin substitutes in dermatology & aesthetics. Last curated .

How FDA classifies these products

Product class	Usual pathway	What decides it
Exosomes / EVs	Section 351: drug/biologic (IND, then BLA)	FDA's position since 2019: no approved exosome products. Applying them after microneedling is treated as administration, not a topical cosmetic use.
Cultured or expanded cells (fibroblast, ADSC/MSC, SVF)	Section 351: BLA, with RMAT available for serious conditions	More-than-minimal manipulation, or non-homologous use, takes a cell product out of the 361 pathway.
Human ECM (ADM, amnion, placental tissue)	Section 361 HCT/P (no premarket review) or device / 351	All four 361 criteria must hold: minimal manipulation, homologous use, no combination, no systemic effect. Labeled and marketed uses can change the answer.
Skin substitutes	Device (PMA/510(k)) or BLA if living cells	Living-cell constructs such as StrataGraft are BLAs; acellular matrices are usually devices.

Compiled for information only; not medical or legal advice. Trial records come from ClinicalTrials.gov; FDA actions from FDA pages. Items marked Verify were reported by a secondary source and should be checked against the FDA document before citing. Maintained by Jane Yoo, MD, MPP on beautytechderm.com.