[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: 21CFR610.42]

[Page 77-78]
 
                        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. 610.42  Restrictions on use for further manufacture of medical devices.

    (a) In addition to labeling requirements in subchapter H of this 
chapter, when a medical device contains human blood or a blood component 
as a component of the final device, and the human blood or blood 
component was found to be reactive by a screening test

[[Page 78]]

performed under Sec. 610.40(a) and (b) or reactive for syphilis under 
Sec. 610.40(i), then you must include in the device labeling a statement 
of warning indicating that the product was manufactured from a donation 
found to be reactive by a screening test for evidence of infection due 
to the identified communicable disease agent(s).
    (b) FDA may approve an exception or alternative to the statement of 
warning required in paragraph (a) of this section based on evidence that 
the reactivity of the human blood or blood component in the medical 
device presents no significant health risk through use of the medical 
device.

[66 FR 31164, June 11, 2001]