Every product in the catalogue is a human cell, tissue, or cellular and tissue-based product regulated solely under Section 361 of the Public Health Service Act and 21 CFR Part 1271. Each is minimally manipulated and intended for homologous use.
Products in this category do not require, and do not have, FDA pre-market clearance or approval. We say so plainly on every product page rather than leaving it to a footnote — the regulatory pathway is a fact about the product, and your value analysis committee will ask.
Complete documentation — establishment registration, accreditation, donor screening and eligibility statements and sterilization validation summaries — is available through the partner portal or on request.