0302 21cfr1270 35

Food and Drug Administration, HHS

§ 1270.41

the performance of infectious disease
screening and testing of donors of
human tissue. All records shall be accurate, indelible, and legible. The
records shall identify the person performing the work, the dates of the various entries, and shall be as detailed as
necessary to provide a complete history of the work performed and to relate the records to the particular tissue
involved.
(b) All human tissue shall be quarantined until the following criteria for
donor suitability are satisfied:
(1) All infectious disease testing
under § 1270.21 has been completed, reviewed by the responsible person, and
found to be negative; and
(2) Donor screening has been completed, reviewed by the responsible person, and determined to assure freedom
from risk factors for and clinical evidence of HIV infection, hepatitis B, and
hepatitis C.
(c) All human tissue processed or
shipped prior to determination of donor
suitability must be under quarantine,
accompanied by records assuring identification of the donor and indicating
that the tissue has not been determined to be suitable for transplantation.
(d) All human tissue determined to
be suitable for transplantation must be
accompanied by a summary of records,
or copies of such original records, documenting that all infectious disease
testing and screening under § 1270.21
has been completed, reviewed by the
responsible person, and found to be
negative, and that the tissue has been
determined to be suitable for transplantation.
(e) Human tissue shall be quarantined until the tissue is either determined to be suitable for transplantation or appropriate disposition is accomplished.
(f) All persons or establishments that
generate records used in determining
the suitability of the donor shall retain
such records and make them available
for authorized inspection or upon request by FDA. The person(s) or establishment(s) making the determination
regarding the suitability of the donor
shall retain all records, or true copies
of such records required under § 1270.21,
including all testing and screening

records, and shall make them available
for authorized inspection or upon request from FDA. Records that can be
retrieved from another location by
electronic means meet the requirements of this paragraph.
(g) Records required under this part
may be retained electronically, or as
original paper records, or as true copies
such as photocopies, microfiche, or
microfilm, in which case suitable reader and photocopying equipment shall
be readily available.
(h) Records shall be retained at least
10 years beyond the date of transplantation if known, distribution, disposition, or expiration, of the tissue,
whichever is latest.
[62 FR 40444, July 29, 1997, as amended at 63
FR 16685, Apr. 6, 1998]

§ 1270.35

Specific records.

Records shall be maintained that include, but are not limited to:
(a) Documentation of results and interpretation of all required infectious
disease tests;
(b) Information on the identity and
relevant medical records of the donor,
as required by § 1270.21(e) in English or,
if in another language translated to
English and accompanied by a statement of authenticity by the translator
which specifically identifies the translated document;
(c) Documentation of the receipt and/
or distribution of human tissue; and
(d) Documentation of the destruction
or other disposition of human tissue.

Subpart D—Inspection of Tissue
Establishments
§ 1270.41

Inspections.

(a) An establishment covered by
these regulations in this part, including any location performing contract
services, shall permit an authorized inspector of the Food and Drug Administration (FDA) to make at any reasonable time and in a reasonable manner
such inspection of the establishment,
its facilities, equipment, processes,
products, and records as may be necessary to determine compliance with
the provisions of this part. Such inspections may be made with or without

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