21cfr1271

Food and Drug Administration, HHS

§ 1271.15

steps to inactivate or remove adventitious agents, preservation for storage, and removal from storage.
(gg) Quality audit means a documented, independent inspection and review of an establishment’s activities
related to core CGTP requirements.
The purpose of a quality audit is to
verify, by examination and evaluation
of objective evidence, the degree of
compliance with those aspects of the
quality program under review.
(hh) Quality program means an organization’s comprehensive system for
manufacturing and tracking HCT/Ps in
accordance with this part. A quality
program is designed to prevent, detect,
and correct deficiencies that may lead
to circumstances that increase the risk
of
introduction,
transmission,
or
spread of communicable diseases.
(ii) Recovery means obtaining from a
human donor cells or tissues that are
intended for use in human implantation, transplantation, infusion, or
transfer.
(jj) Storage means holding HCT/Ps for
future processing and/or distribution.
(kk) Validation means confirmation
by examination and provision of objective evidence that particular requirements can consistently be fulfilled.
Validation of a process, or process validation, means establishing by objective
evidence that a process consistently
produces a result or HCT/P meeting its
predetermined specifications.
(ll) Verification means confirmation
by examination and provision of objective evidence that specified requirements have been fulfilled.
[66 FR 5466, Jan. 19, 2001, as amended at 68
FR 3826, Jan. 27, 2004; 69 FR 29829, May 25,
2004; 69 FR 68680, Nov. 24, 2004]

§ 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 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
(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.
(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.
[66 FR 5466, Jan. 19, 2001, as amended at 69
FR 68681, Nov. 24, 2004]

§ 1271.15 Are there any exceptions
from the requirements of this part?
(a) You are not required to comply
with the requirements of this part if
you are an establishment that uses
HCT/P’s solely for nonclinical scientific or educational purposes.
(b) You are not required to comply
with the requirements of this part if
you are an establishment that removes
HCT/P’s from an individual and implants such HCT/P’s into the same individual during the same surgical procedure.
(c) You are not required to comply
with the requirements of this part if
you are a carrier who accepts, receives,
carries, or delivers HCT/P’s in the
usual course of business as a carrier.
(d) You are not required to comply
with the requirements of this part if
you are an establishment that does not
recover, screen, test, process, label,

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