[Code of Federal Regulations]

[Title 21, Volume 8]

[Revised as of April 1, 2006]

From the U.S. Government Printing Office via GPO Access

[CITE: 21CFR809.3]



[Page 84]

 

                        TITLE 21--FOOD AND DRUGS

 

CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 

                          SERVICES (CONTINUED)

 

PART 809_IN VITRO DIAGNOSTIC PRODUCTS FOR HUMAN USE--Table of Contents

 

                      Subpart A_General Provisions

 

Sec.  809.3  Definitions.









                      Subpart A_General Provisions



Sec.

809.3 Definitions.

809.4 Confidentiality of submitted information.



                           Subpart B_Labeling



809.10 Labeling for in vitro diagnostic products.



         Subpart C_Requirements for Manufacturers and Producers



809.20 General requirements for manufacturers and producers of in vitro 

          diagnostic products.

809.30 Restrictions on the sale, distribution and use of analyte 

          specific reagents.

809.40 Restrictions on the sale, distribution, and use of OTC test 

          sample collection systems for drugs of abuse testing.



    Authority: 21 U.S.C. 331, 351, 352, 355, 360b, 360c, 360d, 360h, 

360i, 360j, 371, 372, 374, 381.







    (a) In vitro diagnostic products are those reagents, instruments, 

and systems intended for use in the diagnosis of disease or other 

conditions, including a 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 

devices as defined in section 201(h) of the Federal Food, Drug, and 

Cosmetic Act (the act), and may also be biological products subject to 

section 351 of the Public Health Service Act.

    (b) A product class is all those products intended for use for a 

particular determination or for a related group of determinations or 

products with common or related characteristics or those intended for 

common or related uses. A class may be further divided into subclasses 

when appropriate.

    (c) [Reserved]

    (d) Act means the Federal Food, Drug, and Cosmetic Act.



[41 FR 6903, Feb. 13, 1976, as amended at 45 FR 7484, Feb. 1, 1980]