[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: 21CFR1270.31]

[Page 712-713]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 1270_HUMAN TISSUE INTENDED FOR TRANSPLANTATION--Table of Contents
 
                    Subpart C_Procedures and Records
 
Sec. 1270.31  Written procedures.


    (a) There shall be written procedures prepared and followed for all 
significant steps in the infectious disease testing process under Sec. 
1270.21 which shall conform to the manufacturers' instructions for use 
contained in the package inserts for the required tests. These 
procedures shall be readily available to the personnel in the area where 
the procedures are performed unless impractical. Any deviation from the 
written procedures shall be recorded and justified.
    (b) There shall be written procedures prepared and followed for all 
significant steps for obtaining, reviewing, and assessing the relevant 
medical records of the donor as provided in Sec. 1270.21. Such 
procedures shall be readily available to personnel who may perform the 
procedures. Any deviation from the written procedures shall be recorded 
and justified.
    (c) There shall be written procedures prepared and followed for 
designating and identifying quarantined tissue.
    (d) There shall be written procedures prepared, validated, and 
followed for prevention of infectious disease contamination or cross-
contamination by tissue during processing.

[[Page 713]]

    (e) In conformity with this section, any facility may use current 
standard written procedures such as those in a technical manual prepared 
by another organization, provided the procedures are consistent with and 
at least as stringent as the requirements of this part.