This document is intended as an inspectional tool to assist FDA Investigators in distinguishing between the human cells, tissues, and cellular and tissue-based products (HCT/P's) that are regulated by the Center for Devices and Radiological Health (CDRH) as medical devices and those that are regulated by the Center for Biologics Evaluation and Research (CBER). A section is also included for combination products (see also Compliance Program Manual 7341.002, Inspection of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps).)

1. CBER

   HCT/P's Regulated under 21 CFR 1271.3(d)(1) and Section 361 of the PHS Act

   These HCT/P's are regulated solely as "361 products" when they meet all of the criteria in 21 CFR 1271.10(a):

   • BONE (including DEMINERALIZED BONE
   • LIGAMENTS
   • TENDONS
   • FASCIA
   • CARTILAGE
   • OCULAR TISSUES (CORNEAS & SCLERA)
   • SKIN
   • VASCULAR GRAFTS (VEINS & ARTERIES), except preserved umbilical cord veins
   • PERICARDIUM
   • AMNIOTIC MEMBRANE (when used alone (-without added cells-) for ocular repair)
   • DURA MATER
   • HEART VALVE ALLOGRAFTS
   • HEMATOPOIETIC STEM CELLS DERIVED FROM PERIPHERAL OR UMBILICAL CORD BLOOD
   • SEMEN
   • OOCYTES
   • EMBRYOS

   HUMAN SOMATIC CELL THERAPY AND GENE THERAPY PRODUCTS Regulated under Section 351 of the PHS Act and/or the FD&C Act

   This grouping includes products that FDA has determined do not meet all of the criteria in 21 CFR 1271.10(a) and are regulated as drugs and/or biological products.

   • CULTURED CARTILAGE CELLS
   • CULTURED NERVE CELLS
   • LYMPHOCYTE IMMUNE THERAPY
   • GENE THERAPY PRODUCTS
   • HUMAN CLONING
   • HUMAN CELLS USED IN THERAPY INVOLVING THE TRANSFER OF GENETIC MATERIAL (cell nuclei, oocyte nuclei, mitochondrial genetic material in ooplasm, genetic material contained in a genetic vector)
   • UNRELATED ALLOGENEIC HEMATOPOIETIC STEM CELLS
   • UNRELATED DONOR LYPHOCYTES FOR INFUSION

2. CDRH

   DEVICES COMPOSED OF HUMAN TISSUES Regulated under the FD&C Act and device regulations

   • CORNEAL LENTICULES
   • PRESERVED UMBILICAL CORD VEIN GRAFTS
   • HUMAN COLLAGEN
   • FEMORAL VEINS INTENDED AS A-V SHUNTS

3. COMBINATION PRODUCTS

   • DEMINERALIZED BONE combined with HANDLING AGENTS (glycerol, sodium hyaluronate, calcium sulfate, gelatin, collagen) - are regulated as DEVICES
   • BONE-SUTURE-TENDON ALLOGRAFTS - regulated as DEVICES
   • CULTURED CELLS (fibroblasts/keratinocytes/nerve/ligament/bone marrow) on SYNTHETIC MEMBRANES or combined with COLLAGEN may be regulated as DEVICES or BIOLOGICAL PRODUCTS (these products are currently under review and may be regulated by CBER under either the device authorities or under section 351 of the PHS Act)
   • ENCAPSULATED PANCREATIC ISLET CELLS are regulated as BIOLOGICAL PRODUCTS

CBER Contact: Hang Dinh (HFM-650) 301-827-6220
CDRH Contact: Gene Berk (HFZ-404) 301-594-1190 ext. 132