An HCT/P that does not meet the applicable section-361 criteria in 21 CFR 1271.10, for instance because it is intended for a non-homologous use or depends on the metabolic activity of living cells for its primary function, generally needs review under other applicable FDA requirements, most often as a drug or biologic under section 351. That pathway treats the product like any other biologic drug, requiring the same premarket licensing process.
FDA has stated publicly that there are no FDA-approved exosome products on the market. Extracellular vesicle and exosome preparations are generally understood to fall under the section 351 framework rather than section 361. FDA has taken enforcement action against companies marketing exosome products for clinical use without a license.
This classification question is not something a distributor resolves on a buyer's behalf. Purchase and clinical use decisions, including any judgment about which regulatory pathway applies to a specific product and intended use, belong to the licensed physician, who should consult their own regulatory counsel rather than relying on marketing material from any supplier.
These products are not FDA approved or licensed for any disease or condition. Information is for licensed healthcare professionals and is not medical or legal advice.
Knowing that exosome products generally sit under section 351 rather than section 361 shapes how a clinic frames its own regulatory review of any exosome purchase.