[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR1270.3]

[Page 687-689]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 1270--HUMAN TISSUE INTENDED FOR TRANSPLANTATION--Table of Contents
 
                      Subpart A--General Provisions
 
Sec. 1270.3  Definitions.

    (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.

[[Page 688]]

    (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 means any tissue derived from a human body, 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

[[Page 689]]

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.