[Code of Federal Regulations]
[Title 21, Volume 4]
[Revised as of April 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR201.119]
[Page 70]
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]
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