Quality & Regulatory

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 manufactures Medical Devices and Human Cell, Tissue, and Cellular and Tissue-Based Products (HCT/Ps). StimLabs’ scope of operations requires adherence to applicable regulations for Medical Devices including the Quality System Regulations (21 CFR Part 820), Labeling (21 CFR Part 801), Medical Device Reporting (21 CFR Part 803), Establishment Listing and Registration including premarket notification (21 CFR Part 806), Recall (21 CFR Part 7, 21 CFR Part 806, 21 CFR Part 810), and Unique Device Identifier (21 CFR Part 830) as well as adherence to all parts of FDA regulation 21 CFR Part 1271 for Section 361 HCT/Ps.

01 FDA Classification

Medical Devices

StimLabs manufacturers and distributes products classified by the FDA as HCT/Ps that are regulated as medical devices; as such, these products are subject to premarket notification, also known as a 510(k), with clearance from the FDA demonstrating that the device is safe and effective¹ prior to marketing in the United States.

Section 361 HCT/Ps

StimLabs processes and distributes tissue products 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 CFR Part 1271.10, set out the specific criteria that a tissue product must meet in order to be marketed without prior approval or clearance from FDA.

StimLabs’ Section 361 HCT/Ps are minimally manipulated, are intended for homologous use only, are not combined with any article that raises new clinical safety concerns, do not have a systemic effect, and/or are not dependent upon metabolic activity of living cells to achieve the primary function; therefore, these products are exempt from FDA premarket notification and approval requirements.

¹The premarket notification process allows the FDA to determine if a device is substantially equivalent to, and therefore as safe and effective as, a legally marketed predicate device that is not subject to premarket approval (PMA).

02 FDA Establishment Registration and Listing

StimLabs is registered as a Medical Device facility for the manufacturing and complaint file handling of Medical Devices manufactured by StimLabs and has appropriately listed all devices currently manufactured and distributed by StimLabs.

Medical Device Establishment Registration and Listing – 3012823434

StimLabs is also a tissue bank registered with the FDA as a Tissue Establishment and has appropriately listed all HCT/Ps currently recovered, screened, packaged, processed, stored, labeled and distributed by StimLabs.

FDA Tissue Bank Establishment Registration– 3012823434

03 State Licenses

In addition to FDA regulations, some states require licensure for operations. StimLabs has applied for licensure in all states where applicable, based on the scope of StimLabs’ operations.
Contact us if you have any additional questions regarding state regulations or licensure requirements.

04 American Association of Tissue Banks Accreditation

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.

05 Donor Eligibility

Each donor tissue is evaluated by the Quality Assurance Unit for eligibility based on the donor eligibility 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 StimLabs’ Medical Director, a board-certified pathologist qualified to evaluate infectious disease testing results and medical records.

06 Donor Testing

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.

07 Current Good Tissue Practice (21 CFR Section 1271.145), Current Good Manufacturing Practices/Quality System Regulations (21 CFR 820), and AATB Standards for Tissue Banking

StimLabs is a manufacturer of HCT/Ps as well as Medical Devices that are subject to 21 CFR 1271 Subparts C and D, and we have therefore developed a comprehensive Quality Management System to meet all FDA, State, and AATB requirements including subsystems to address each mandatory core element.

FDA’s cGMP requirements govern the methods used in, and the facilities and controls used for, the design, manufacture, packaging, labeling, storage, installation, and servicing of all finished Medical Devices intended for human use and are intended to ensure that finished devices will be safe and effective and otherwise in compliance with the Federal Food, Drug, and Cosmetic Act.

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.