21 CFR 809.3 - Definitions.

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§ 809.3 Definitions.

(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]

Title 21 published on 10-May-2017 03:43

The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR Part 809 after this date.

  • 2016-06-15; vol. 81 # 115 - Wednesday, June 15, 2016
    1. 81 FR 38911 - Use of Symbols in Labeling
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final rule.
      This rule is effective September 13, 2016.
      21 CFR Parts 660, 801, and 809