Last updated April 1, 2021
ORCA BIOTECH LLC (“Orca”) distributes human cells, tissues, and cellular and tissue-based products (“HCT/P”) pursuant to Title 21, Part 1271 of the Code of Federal Regulations (21 C.F.R. 1271). Orca’s HCT/P products are intended for “homologous use” only as that term is defined in 21 C.F.R. 1271.3(c).
Orca’s distribution of HCT/P products conforms with the following criteria set forth in 21 C.F.R. 1271.10 (Section 361 of the PHS Act):
1. The HCT/P is minimally manipulated as defined in 21 C.F.R. 1271.3(f):
Minimal manipulation means: (1) For structural tissue, processing that does not alter the original relevant characteristics of the tissue relating to the tissue’s utility for reconstruction, repair, or replacement; and (2) For cells or nonstructural tissues, processing that does not alter the relevant biological characteristics of cells or tissues;
2. The HCT/P is intended for homologous use only, as reflected by the labeling, advertising, or other indications of the manufacturer’s objective intent;
3. The manufacture of the HCT/P does not involve the combination of the cells or tissues with another article, except for water, crystalloids, or a sterilizing, preserving, or storage agent, provided that the addition of water, crystalloids, or the sterilizing, preserving, or storage agent does not raise new clinical safety concerns with respect to the HCT/P; and
4. The HCT/P does not have a systemic effect and is not dependent upon the metabolic activity of living cells for its primary function; or the HCT/P is for autologous use and has a systemic effect or is dependent upon the metabolic activity of living cells for its primary function.
Pursuant to 21 C.F.R. 1271, Orca is registered with the FDA’s Human Cell and Tissue Establishment Registration (HCTERS) service. A link to the HCTERS database can be found here. When searching the database, search for “ORCA BIOTECH.”
As a distributor of HCT/P’s regulated under Section 361 of the Public Health Service Act, Orca is required to comply with FDA’s Current Good Tissue Practice (“CGTP”) regulation (21 C.F.R. 1217.145 et seq.) to prevent the introduction, transmission, or spread of communicable diseases. Pursuant to Section 351 of the Public Health Service Act, drug manufacturers are required to comply with the FDA’s Current Good Manufacturing Practice (“CGMP”). Although Orca’s HCT/P products are not regulated as drugs under Section 351 of the Public Health Service Act, Orca complies with aspects of the FDA’s Current Good Manufacturing Practice that are consistent with CGTP.
U.S. Code Annotated, Federal Food, Drug, and Cosmetic Act (21 U.S.C.A. 301 et seq.)
ORCA’S HCT/P PRODUCTS ARE NOT DRUGS INTENDED FOR USE IN THE DIAGNOSIS, CURE, MITIGATION, TREATMENT, OR PREVENTION OF DISEASE (21 U.S.C.A. 321(G)). Unless specifically stated, no statements on this website have been evaluated or approved by the FDA. Orca does not claim that any applications, or potential applications, using Orca products are approved by the FDA, or are even effective. Orca does not claim that these products or associated therapies work for any listed nor unlisted condition—intended or implied.
Orca does not provide medical advice. It is important for potential patients to do their own research and consult with their healthcare provider so that they can make an informed decision. Whether or not a specific use of Orca’s products is a homologous use is determined by the prescribing physician at the time of product use.
ORCA DISCLAIMS ALL THIRD-PARTY CLAIMS, ADVERTISEMENTS, AND MARKETING MATERIALS REFERENCING ORCA, OR ITS PRODUCTS, OTHER THAN THOSE SPECIFICALLY APPROVED AND DISSEMINATED BY AN AUTHORIZED REPRESENTATIVE OF ORCA.