REGULATORY & COMPLIANCE

BioWellness Group only works with manufacturers that maintain a quality program designed to prevent, detect and correct deficiencies that may lead to circumstances that increase the risk of introduction, transmission and spread of communicable diseases. The scope of the quality program applies to the products, services and employees and to applicable contracted service providers. 

The processing of these products aligns with the minimal manipulation requirements identified by the FDA to ensure they are free from potential contaminants or harmful components. Further, the processing of the products does not alter the relevant biological characteristics of cells or tissues.


HOMOLOGUS USE

Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P) are defined in 21 CFR 1271.3(d) as articles containing or consisting of human cells or tissues that are intended for transplantation, infusion or transfer into a human recipient to assist in the body’s natural regenerative functions.

These products are cells / nonstructural tissues that serve predominantly metabolic or other biochemical roles in the body such as hematopoietic, immune and endocrine functions.

These products are intended for homologous use, on a single patient, one time use only. They are used by licensed medical professionals (e.g., physician) on patients.

Minimal Manipulation Compliance Rationale

Based on an evaluation of FDA regulations, FDA Guidance Documents (e.g., Regulatory Considerations for Human Cell, Tissues, and Cellular and Tissue-Based Products: Minimal Manipulation and Homologous Use, November 2017, and Tissue Reference Group (TRG) documents, BioWellness Group's products are minimally manipulated and align to the regulatory factors in the table below.

Minimal Manipulation Compliance Rationale Table
OUR PRODUCT AREOUR PRODUCTS ARE NOT
Cells or nonstructural tissues that serve predominantly metabolic or other biochemical roles in the body such as hematopoietic, immune and endocrine functions(FDA Guidance Document – Regulatory Considerations for Human Cell, Tissues, and Cellular and Tissue-Based Products: Minimal Manipulation and Homologous Use).
Processed in any way that alters relevant biological characteristics of cells or nonstructural tissues (21 CFR 1271.3(f)(2)).
Intended for homologous use to supplement the recipient’s tissue and assist in the body’s natural regenerative functions (Reference instructions for use).
Manufactured in any way that involves the combination of 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 a sterilizing, preserving, or storage agent does not raise new clinical safety concerns with respect to the HCT/P (21 CFR 1271.10(a)(3).
Intended for homologous use only, as reflected by the labeling, advertising or other indications of the manufacturer’s objective intent (21 CFR 1271.10(a)(2)).
Dependent on having a systemic effect upon the metabolic activity of living cells for its primary function (21 CFR 1271.10(a)(4)(i)).
Minimally manipulated via processing procedures that include separation, cutting, grinding and shaping(FDA Guidance Document – Regulatory Considerations for Human Cell, Tissues, and Cellular and Tissue-Based Products: Minimal Manipulation and Homologous Use).
Incubated in a laboratory vessel where the processing affects the production of intracellular or cell-surface proteins or other markers of cell lineage, activation state and proliferation, thereby altering the cells’ biological characteristics of multipotency and capacity for self-renewal(FDA Guidance Document – Regulatory Considerations for Human Cell, Tissues, and Cellular and Tissue-Based Products: Minimal Manipulation and Homologous Use).
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