[Code of Federal Regulations]
[Title 21, Volume 4]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR201.119]

[Page 53]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 201--LABELING--Table of Contents
 
         Subpart D--Exemptions From Adequate Directions for Use
 
Sec. 201.119  In vitro diagnostic products.

    (a) ``In vitro diagnostic products'' are those reagents, instruments 
and systems intended for use in the diagnosis of disease or in the 
determination of the state of health in order to cure, mitigate, treat, 
or prevent disease or its sequelae. Such products are intended for use 
in the collection, preparation and examination of specimens taken from 
the human body. These products are drugs or devices as defined in 
section 201(g) and 201(h), respectively, of the Federal Food, Drug, and 
Cosmetic Act (the act) or are a combination of drugs and devices, and 
may also be a biological product subject to section 351 of the Public 
Health Service Act.
    (b) A product intended for use in the diagnosis of disease and which 
is an in vitro diagnostic product as defined in paragraph (a) of this 
section shall be deemed to be in compliance with the requirements of 
this section and section 502(f)(1) of the act if it meets the 
requirements of Sec. 809.10 of this chapter.

[41 FR 6910, Feb. 13, 1976]