[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: 21CFR1271.3]

[Page 693-694]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 1271--HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS--Table of Contents
 
                      Subpart A--General Provisions
 
Sec. 1271.3  How does FDA define important terms in this part?

    The following definitions apply only to this part:
    (a) Autologous use means the implantation, transplantation, 
infusion, or transfer of human cells or tissue back into the individual 
from whom the cells or tissue were recovered.
    (b) Establishment means a place of business under one management, at 
one general physical location, that engages in the manufacture of human 
cells, tissues, and cellular and tissue-based products. 
``Establishment'' includes:
    (1) Any individual, partnership, corporation, association, or other 
legal entity engaged in the manufacture of human cells, tissues, and 
cellular and tissue-based products; and
    (2) Facilities that engage in contract manufacturing services for a 
manufacturer of human cells, tissues, and cellular and tissue-based 
products.
    (c) Homologous use means the replacement or supplementation of a 
recipient's cells or tissues with an HCT/P that performs the same basic 
function or functions in the recipient as in the donor.
    (d)(1) Human cells, tissues, or cellular or tissue-based products 
(HCT/P's) means any human tissue derived from a human body and intended 
for transplantation into another human, as defined under Sec. 1270.3(j). 
Examples of HCT/P's include, but are not limited to, bone, ligament, 
skin, and cornea.
    (2) Human cells, tissues, or cellular or tissue-based products (HCT/
P's) means articles containing or consisting of human cells or tissues 
that are intended for implantation, transplantation, infusion, or 
transfer into a human recipient. Examples of HCT/P's include, but are 
not limited to, bone, ligament, skin, dura mater, heart valve, cornea, 
hematopoietic stem cells derived from peripheral and cord blood, 
manipulated autologous chondrocytes, epithelial cells on a synthetic 
matrix, and semen or other reproductive tissue. The following articles 
are not considered HCT/P's:
    (i) Vascularized human organs for transplantation;
    (ii) Whole blood or blood components or blood derivative products 
subject to listing under parts 607 and 207 of this chapter, 
respectively;
    (iii) Secreted or extracted human products, such as milk, collagen, 
and cell factors; except that semen is considered an HCT/P;
    (iv) Minimally manipulated bone marrow for homologous use and not 
combined with a drug or a device (except for a sterilizing, preserving, 
or storage agent, if the addition of the agent does not raise new 
clinical safety concerns with respect to the bone marrow);
    (v) Ancillary products used in the manufacture of HCT/P;
    (vi) Cells, tissues, and organs derived from animals other than 
humans; and
    (vii) In vitro diagnostic products as defined in Sec. 809.3(a) of 
this chapter.

[[Page 694]]

    (e) Manufacture means, but is not limited to, any or all steps in 
the recovery, processing, storage, labeling, packaging, or distribution 
of any human cell or tissue, and the screening or testing of the cell or 
tissue donor.
    (f) Minimal manipulation means:
    (1) For structural tissue, processing that does not alter the 
original relevant characteristics of the tissue relating to the tissue's 
utility for reconstruction, repair, or replacement; and
    (2) For cells or nonstructural tissues, processing that does not 
alter the relevant biological characteristics of cells or tissues.
    (g) Transfer means the placement of human reproductive cells or 
tissues into a human recipient.

    Effective Date Note: At 66 FR 5466, Jan. 19, 2001, part 1271, 
consisting of Secs. 1271.1-1271.37, was added, effective Apr. 4, 2001, 
except for Sec. 1271.3(d)(2) which is effective Jan. 21, 2003. At 68 FR 
2689, Jan. 21, 2003, the effective date was delayed until Jan. 21, 2004.