36C10G18R0003 Biologics

Read the official notice on SAM.gov

Summary from the notice

PRE-SOLICITATION NOTICE: The Department of Veterans Affairs (VA), Strategic Acquisition Center in Fredericksburg, Virginia intends to issue a solicitation for the procurement of various types of biologics and biological implants, which include any human cell, tissue, or cellular or tissue-based product or animal product inserted or grafted into the body for prosthetic, therapeutic purposes. These biologics and biological implants are to be used in various surgeries and medical procedures to treat, prevent, or diagnose diseases. Biologic implants will consist of Allograft and Xenograft tissue. Allografts are bone and soft tissue grafts taken from human cadavers of genetically non-identical member of the same species. Most human tissue and organ transplants are Allografts. Xenografts are bone and soft-tissue grafts taken from animals, typically pigs and cows. All products shall be Food and Drug Administration (FDA) approved and labeled in accordance with the International Standard for Blood and Transplant (ISBT) 128 only for Medical Products of Human Origin, such as Allografts, which is the global standard for the identification, labeling, and information transfer of medical products used in the VA. Biological implants must be tracked from human donor or animal source at each step of distribution to implantation so that all patients who receive a biological implant by the VA can be notified of a recall subject to the evaluation by appropriate medical personnel. The Government i…

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