Regulatory Compliance, Patient Safety, and Quality Assurance
Patient safety is the highest priority at StimLabs and our quality, regulatory, and donor screening systems are a direct reflection of that commitment.
StimLabs’ tissue products are regulated by the FDA as a Human Cell, Tissue, and Cellular and Tissue-Based Product (HCT/P) solely under Section 361 of the Public Health Service (PHS) Act. The FDA requires adherence to the FDA regulation (21 CFR Part 1271), including Establishment Registration, Donor Testing, Donor Eligibility Determination and current Good Tissue Practice (cGTP) Quality System Regulations.
StimLabs’ tissue products are classified as Human Cell, Tissue, and Cellular and Tissue-Based Products (HCT/Ps), which are regulated solely under Section 361 of the Public Health Service (PHS) Act. FDA’s regulations, 21 C.F.R. Part 1271, set out the criteria that a tissue product must meet in order to be marketed without prior approval or clearance from FDA.
According to Section 1271.10, “[a]n HCT/P is regulated solely under Section 361 of the Public Health Service Act and the implementing regulations if it meets all of the following criteria:
- The HCT/P is minimally manipulated;
- The HCT/P is intended for homologous use only, as reflected by the labeling, advertising, or other indications of the manufacturer’s objective intent;
- 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
- The HCT/P does not have a systemic effect and is not dependent upon the metabolic activity of living cells for its primary function.
Products meeting the above criteria are exempt from FDA pre-market approval requirements.
StimLabs is registered with the FDA as a Tissue Establishment and has listed all HCT/Ps currently recovered, screened, packaged, processed, stored, labeled and distributed by StimLabs with the Agency:
FDA Tissue Bank Establishment Registration – 3012823434
In addition to FDA regulations, some states require licensure for Tissue Banks. StimLabs has applied for licensure in all states where applicable, based on the scope of StimLabs’ operations.
- Oregon – StimLabs is on the Oregon Procurement Organizations/Tissue Bank Registry
- Maryland – Tissue Bank License Number TB2502
- California – Tissue Bank License Number CNC81215
- New York – Tissue Bank ID Number CP201TP170
- Georgia – Clinical Laboratory License Number 060-395
- Illinois – Tissue Registration Number 0219
- Delaware – Tissue Bank Registry
StimLabs is proud to have earned the distinction of an AATB Accredited Tissue Bank. Accreditation follows an intensive application process that includes on-site inspection by a trained AATB inspector. Through the process, AATB establishes that a tissue bank’s operations meet or exceed the standards set by the AATB, ensuring that the methods, procedures, personnel, equipment and facilities satisfy the established requirements. StimLabs has met the stringent accreditation requirements of the AATB and is accredited for acquisition processing, release, storage, distribution and donor eligibility assessment for birth tissue. Our Accreditation Number is 00243.
Each donor tissue is evaluated by the Quality Assurance Unit for eligibility based on the donor suitability criteria current at the time of tissue recovery and/or acquisition in accordance with FDA regulations, local and state regulations and StimLabs protocols. Donor eligibility is determined through a review of donor medical/social history, informed consent documentation and medical records to verify that there is not an increased risk of transmissible infectious disease such as spongiform encephalopathy (including Creutzfeldt-Jakob disease), and additional risks associated with xenotransplantation. Final donor eligibility determination is made by the StimLabs’ Medical Director, a board-certified pathologist qualified to evaluate infectious disease testing results and medical records.
All relevant communicable disease testing is performed by a laboratory registered with the FDA to perform donor testing and certified to perform testing on human specimens under the Clinical Laboratory Improvement Amendments of 1988 (42 U.S.C. 263a) and 42 CFR part 493, or meeting equivalent requirements, as determined by the Centers for Medicare and Medicaid Services (CMS). Testing is performed using only FDA-licensed, approved, or cleared donor screening test kits. The testing laboratories are evaluated and approved according to the StimLabs Supplier Qualification and Control procedure. Donor Infectious Disease Testing includes, at a minimum, the following:
- HTLV-1 and HTLV-2 Antibody
- HIV-1/HCV/HBV Nucleic Acid Test (NAT)
- HIV-1 and HIV-2 Plus O Antibody
- Cytomegalovirus (CMV) Total Antibody
- Serological Test for Syphilis (Treponema pallidum)
- Hepatitis C Virus Antibody
- Hepatitis B Core Total Antibody
- Hepatitis B Surface Antigen
- West Nile Virus Nucleic Acid-Test (during active mosquito season per FDA Guidance)*
All results for Infectious Disease Testing are reviewed prior to the release of the donor tissue to verify compliance with both internal and external regulatory requirements put into place to prevent the transmission of communicable disease.
* Food and Drug Administration. Use of Nucleic Acid Tests to Reduce the Risk of Transmission of West Nile Virus from Living Donors of Human Cells, Tissue, and Cellular and Tissue-Based Products (HCT/Ps). Guidance for Industry. September, 2016.
FDA’s cGTP requirements govern the methods used in, and the facilities and controls used for, the manufacture and processing of HCT/Ps in a way that prevents the introduction, transmission, and spread of communicable diseases. StimLabs has developed a comprehensive Quality Management System to meet the requirements of both 21 CFR 1271.145 and the American Association of Tissue Banks Standards for Tissue Banking (14th Ed.) that includes subsystems for each mandatory core element.