The following definitions apply only to this part:
(a)
(b)
(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)
(d)(1)
(2)
(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
(v) Ancillary products used in the manufacture of HCT/P;
(vi) Cells, tissues, and organs derived from animals other than humans;
(vii) In vitro diagnostic products as defined in § 809.3(a) of this chapter; and
(viii) Human dura mater and human heart valve allografts.
(e)
(f)
(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)
1. At 69 FR 29829, May 25, 2004, § 1271.3 was amended by adding paragraphs (h) through (x), effective May 25, 2005. For the convenience of the user, the added text is set forth as follows:
(h)
(i)
(j)
(1) A protein or polysaccharide solution, such as albumin, dextran, or hetastarch, that can be used to increase or maintain osmotic (oncotic) pressure in the intravascular compartment; or
(2) Blood components such as plasma and platelets.
(k)
(l)
(m)
(n)
(1) With the donor, if the donor is living and able to participate in the interview, or
(2) If not, with an individual or individuals able to provide the information sought in the interview (e.g., the donor's next-of-kin, the nearest available relative, a member of the donor's household, an individual with an affinity relationship, and/or the primary treating physician).
(o)
(p)
(q)
(r)
(1)(i) For all human cells and tissues, a communicable disease or disease agent listed as follows:
(A) Human immunodeficiency virus, types 1 and 2;
(B) Hepatitis B virus;
(C) Hepatitis C virus;
(D) Human transmissible spongiform encephalopathy, including Creutzfeldt-Jakob disease; and
(E)
(ii) For viable, leukocyte-rich cells and tissues, a cell-associated disease agent or disease listed as follows:
(A) Human T-lymphotropic virus, type I; and
(B) Human T-lymphotropic virus, type II.
(iii) For reproductive cells or tissues, a disease agent or disease of the genitourinary tract listed as follows:
(A)
(B)
(2) A disease agent or disease not listed in paragraph (r)(1) of this section:
(i) For which there may be a risk of transmission by an HCT/P, either to the recipient of the HCT/P or to those people who may handle or otherwise come in contact with it, such as medical personnel, because the disease agent or disease:
(A) Is potentially transmissible by an HCT/P and
(B) Either of the following applies:
(
(
(ii) That could be fatal or life-threatening, could result in permanent impairment of a body function or permanent damage to body structure, or could necessitate medical or surgical intervention to preclude permanent impairment of body function or permanent damage to a body structure; and
(iii) For which appropriate screening measures have been developed and/or an appropriate screening test for donor specimens has been licensed, approved, or cleared for such use by FDA and is available.
(s)
(1) Laboratory test results (other than results of testing for relevant communicable disease agents required under this subpart);
(2) Medical records;
(3) Coroner and autopsy reports; and
(4) Records or other information received from any source pertaining to risk factors for relevant communicable disease (e.g., social behavior, clinical signs and symptoms of relevant communicable disease, and treatments related to medical conditions suggestive of risk for relevant communicable disease).
(t)
(u)
(v)
(w)
(x)
2. At 69 FR 68680, Nov. 24, 2004, § 1271.3 was amended by revising paragraphs (c) and (d) and adding paragraphs (y) through (ll), effective May 25, 2005. For the convenience of the user, the revised and added text is set forth to read as follows:
(c)
(1) Vascularized human organs for transplantation;
(2) Whole blood or blood components or blood derivative products subject to listing under parts 607 and 207 of this chapter, respectively;
(3) Secreted or extracted human products, such as milk, collagen, and cell factors; except that semen is considered an HCT/P;
(4) Minimally manipulated bone marrow for homologous use and not combined with another article (except for water, crystalloids, or 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);
(5) Ancillary products used in the manufacture of HCT/P;
(6) Cells, tissues, and organs derived from animals other than humans; and
(7) In vitro diagnostic products as defined in § 809.3(a) of this chapter.
(y)
(z)
(aa)
(1) That an HCT/P has transmitted or may have transmitted a communicable disease to the recipient of the HCT/P; or
(2) Any other problem with an HCT/P relating to the potential for transmission of communicable disease, such as the failure to comply with current good tissue practice.
(bb)
(cc)
(dd)
(1) That represents a deviation from applicable regulations in this part or from applicable standards or established specifications that relate to the prevention of communicable disease transmission or HCT/P contamination; or
(2) That is an unexpected or unforeseeable event that may relate to the transmission or potential transmission of a communicable disease or may lead to HCT/P contamination.
(ee)
(ff)
(gg)
(hh)
(ii)
(jj)
(kk)
(ll)