[Code of Federal Regulations]
[Title 21, Volume 7]
[Revised as of April 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR610.42]

[Page 80-81]
 
                        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 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).

[[Page 81]]

    (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]