[Code of Federal Regulations]
[Title 21, Volume 7]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR610.44]

[Page 78]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 610--GENERAL BIOLOGICAL PRODUCTS STANDARDS--Table of Contents
 
     Subpart E--Testing Requirements for Communicable Disease Agents
 
Sec. 610.44  Use of reference panels by manufacturers of test kits.

    (a) When available and appropriate to verify acceptable sensitivity 
and specificity, you, a manufacturer of test kits, must use a reference 
panel you obtain from FDA or from an FDA designated source to test lots 
of the following products. You must test each lot of the following 
products, unless FDA informs you that less frequent testing is 
appropriate, based on your consistent prior production of products of 
acceptable sensitivity and specificity:
    (1) A test kit approved for use in testing donations of human blood 
and blood components for evidence of infection due to communicable 
disease agents listed in Sec. 610.40(a); and
    (2) Human immunodeficiency virus (HIV) test kit approved for use in 
the diagnosis, prognosis, or monitoring of this communicable disease 
agent.
    (b) You must not distribute a lot that is found to be not acceptable 
for sensitivity and specificity under Sec. 610.44(a). FDA may approve an 
exception or alternative to this requirement. Applicants must submit 
such requests in writing. However, in limited circumstances, such 
requests may be made orally and permission may be given orally by FDA. 
Oral requests and approvals must be promptly followed by written 
requests and written approvals.

[66 FR 31164, June 11, 2001]