Regulatory Classification

mVASC is regulated by the U.S. Food and Drug Administration (FDA) as a Human Cells, Tissues and Cellular and Tissue-Based Product (HCT/P), and produced in accordance with FDA regulations for Good Tissue Practices (21 CFR 1270,1271).

It is restricted to homologous use the for repair, reconstruction, replacement or supplementation of microvascular tissue.

Product Safety and Quality Assurance

Product safety and quality is MVT’s number one priority.  Rigorous donor screening/testing, along with aseptic tissue processing in accordance with FDA current Good Tissue Practice, as well as terminal sterilization to a sterility assurance level (SAL) of 10-6, further assures mVASC product safety and quality.

mVASC is procured from donors that meet strict safety criteria, including: medical record and medical history review; physical examination; risk factors for communicable diseases; and independent, serological laboratory testing that is negative for the following tests:

     • Antibodies to human immunodeficiency virus type 1 and type 2, Nucleic acid test (NAT) for HIV-1

     • Hepatitis B surface antigen and core antibody

     • Hepatitis C antibody and NAT

     • Antibodies to HTLV-1 and HTLV-2

     • NAT for HBV

     • Treponema pallidum (syphilis)

  

 

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