(a) The regulations in this part apply to human tissue and to establishments or persons engaged in the recovery, screening, testing, processing, storage, or distribution of human tissue.

(b) Regulations in this chapter as they apply to drugs, biologics, devices, or other FDA-regulated commodities do not apply to human tissue, except as specified in this part.

(c) Regulations in this chapter do not apply to autologous human tissue.

(d) Regulations in this chapter do not apply to hospitals or other clinical facilities that receive and store human tissue only for transplantation within the same facility.

(a) Act for the purpose of this part means the Public Health Service Act, section 361 (42 U.S.C. 264).

(b) Blood component means any part of a single-donor unit of blood separated by physical or mechanical means.

(c) Colloid means a protein or polysaccharide solution that can be used to increase or maintain osmotic (oncotic) pressure in the intravascular compartment such as albumin, dextran, hetastarch; or certain blood components, such as plasma and platelets.

(d) Contract services are those functions pertaining to the recovery, screening, testing, processing, storage, or distribution of human tissue that another establishment agrees to perform for a tissue establishment.

(e) Crystalloid means a balanced salt and/or glucose solution used for electrolyte replacement or to increase intravascular volume such as saline, Ringer's lactate solution, or 5 percent dextrose in water.

(f) Distribution includes any transfer or shipment of human tissue (including importation or exportation), whether or not such transfer or shipment is entirely intrastate and whether or not possession of the tissue is taken.

(g) Donor means a human being, living or dead, who is the source of tissue for transplantation.

(h) Donor medical history interview means a documented dialogue with an individual or individuals who would be knowledgeable of the donor's relevant medical history and social behavior; such as the donor if living, the next of kin, the nearest available relative, a member of the donor's household, other individual with an affinity relationship, and/or the primary treating physician. The relevant social history includes questions to elicit whether or not the donor met certain descriptions or engaged in certain activities or behaviors considered to place such an individual at increased risk for HIV and hepatitis.

(i) Establishment means any facility under one management including all locations, that engages in the recovery, screening, testing, processing, storage, or distribution of human tissue intended for transplantation.

(j) Human tissue, for the purpose of this part means any tissue derived from a human body and recovered before May 25, 2005, which:

(1) Is intended for transplantation to another human for the diagnosis, cure, mitigation, treatment, or prevention of any condition or disease;

(2) Is recovered, processed, stored, or distributed by methods that do not change tissue function or characteristics;

(3) Is not currently regulated as a human drug, biological product, or medical device;

(4) Excludes kidney, liver, heart, lung, pancreas, or any other vascularized human organ; and

(5) Excludes semen or other reproductive tissue, human milk, and bone marrow.

(k) Importer of record means the person, establishment or their representative responsible for making entry of imported goods in accordance with all laws affecting such importation.

(l) Legislative consent means relating to any of the laws of the various States that allow the medical examiner or coroner to procure corneal tissue in the absence of consent of the donor's next-of-kin.

(m) Person includes an individual, partnership, corporation, association, or other legal entity.

(n) Physical assessment means a limited autopsy or recent antemortem or postmortem physical examination of the donor to assess for any signs of HIV and hepatitis infection or signs suggestive of any risk factor for such infections.

(o) Plasma dilution means a decrease in the concentration of the donor's plasma proteins and circulating antigens or antibodies resulting from the transfusion of blood or blood components and/or infusion of fluids.

(p) Processing means any activity performed on tissue, other than tissue recovery, including preparation, preservation for storage, and/or removal from storage to assure the quality and/or sterility of human tissue. Processing includes steps to inactivate and remove adventitious agents.

(q) Quarantine means the identification of human tissue as not suitable for transplantation, including human tissue that has not yet been characterized as being suitable for transplantation. Quarantine includes the storage of such tissue in an area clearly identified for such use, or other procedures, such as automated designation, for prevention of release of such tissue for transplantation.

(r) Reconstituted blood means the extracorporeal resuspension of a blood unit labeled as “Red Blood Cells” by the addition of colloids and/or crystalloids to produce a hematocrit in the normal range.

(s) Recovery means the obtaining from a donor of tissue that is intended for use in human transplantation.

(t) Relevant medical records means a collection of documents including a donor medical history interview, a physical assessment of the donor, laboratory test results, medical records, existing coroner and autopsy reports, or information obtained from any source or records which may pertain to donor suitability regarding high risk behaviors, clinical signs and symptoms for HIV and hepatitis, and treatments related to medical conditions suggestive of such risk.

(u) Responsible person means a person who is authorized to perform designated functions for which he or she is trained and qualified.

(v) Storage means holding tissue.

(w) Summary of records means a condensed version of the required testing and screening records that contains the identity of the testing laboratory, the listing and interpretation of all required infectious disease tests, and a listing of the documents reviewed as part of the relevant medical records, and the name of the person or establishment determining the suitability of the human tissue for transplantation.

(x) Vascularized means containing the original blood vessels which are intended to carry blood after transplantation.