This criterion separates tissue products that act locally and structurally from products whose primary function depends on biological activity throughout the body or on living cells doing something metabolically active. A product that falls into the latter category is pushed toward the section 351 biologics pathway instead of section 361, regardless of how it is otherwise processed.
FDA states there are no FDA-approved exosome products. These products are generally regulated as biologic drugs under section 351. Decisions about purchasing or clinically using an exosome product belong to the physician, working with their own regulatory counsel.
Whether a specific product and intended use trips this criterion is a legal and scientific determination, not something a distributor can settle through a product description. Clinics should review a supplier's documentation on this point with their own regulatory counsel rather than treating any marketing statement, including this one, as a final answer.
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.
This criterion is part of why vesicle-based products are generally discussed under a different regulatory pathway than structural tissue products, which should inform how a clinic frames its own review.