[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2005]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR1271.10]

[Page 719-720]
 
                        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. 1271.10  Are my HCT/P's regulated solely under section 361 of the 
PHS Act and the regulations in this part, and if so what must I do?

    (a) An HCT/P is regulated solely under section 361 of the PHS Act 
and the regulations in this part if it meets all of the following 
criteria:
    (1) The HCT/P is minimally manipulated;
    (2) The HCT/P is intended for homologous use only, as reflected by 
the labeling, advertising, or other indications of the manufacturer's 
objective intent;
    (3) The manufacture of the HCT/P does not involve the combination of 
the cell or tissue component 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 HCT/P; 
and
    (4) Either:
    (i) The HCT/P does not have a systemic effect and is not dependent 
upon the metabolic activity of living cells for its primary function; or
    (ii) The HCT/P has a systemic effect or is dependent upon the 
metabolic activity of living cells for its primary function, and:
    (a) Is for autologous use;
    (b) Is for allogeneic use in a first-degree or second-degree blood 
relative; or
    (c) Is for reproductive use.

[[Page 720]]

    (b) If you are a domestic or foreign establishment that manufactures 
an HCT/P described in paragraph (a) of this section:
    (1) You must register with FDA;
    (2) You must submit to FDA a list of each HCT/P manufactured; and
    (3) You must comply with the other requirements contained in this 
part.

    Effective Date Note: At 69 FR 68681, Nov. 24, 2004, Sec. 1271.10 
was amended by revising paragraph (a)(3), effective May 25, 2005. For 
the convenience of the user, the revised text is set forth as follows:

Sec. 1271.10  Are my HCT/Ps regulated solely under section 361 of the 
          PHS Act and the regulations in this part, and if so what must 
          I do?

    (a) * * *
    (3) The manufacture of the HCT/P does not involve the combination of 
the cells or tissues with another article, except for water, 
crystalloids, or a sterilizing, preserving, or storage agent, provided 
that the addition of water, crystalloids, or the sterilizing, 
preserving, or storage agent does not raise new clinical safety concerns 
with respect to the HCT/P; and

                                * * * * *