The HCT/P category covers a wide range of products, from bone and skin allografts to umbilical cord tissue preparations. It is defined in FDA regulation at 21 CFR Part 1271 and is the starting classification question for any human tissue product: once something is identified as an HCT/P, the next question is which regulatory pathway applies to it.
Some HCT/Ps qualify for regulation solely under section 361 of the Public Health Service Act, which does not require premarket approval if the product meets specific criteria around manipulation and intended use. Products failing section-361 criteria need review under other applicable FDA requirements, generally as drugs or biologics under section 351, which requires a biologics license before marketing for clinical use. Exosomes are generally section-351 biologic drugs.
Request applicable registration, donor eligibility and processing documentation. Counsel should assess which specific Part 1271 requirements apply to a given product and pathway, since this is not uniform across the HCT/P category.
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. FDA states no exosome product is FDA approved. Exosome products are generally regulated as biologic drugs under section 351, and decisions on purchase and clinical use rest with the physician and their regulatory counsel.
Confirming a product's HCT/P classification, and which pathway a supplier believes applies, gives a clinic a starting point for its own regulatory review before purchase.