21 CFR 201.119 - In vitro diagnostic products.

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§ 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 § 809.10 of this chapter.

[41 FR 6910, Feb. 13, 1976]

Title 21 published on 2015-04-01

The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR Part 201 after this date.

  • 2015-11-30; vol. 80 # 229 - Monday, November 30, 2015
    1. 80 FR 74737 - Clarification of When Products Made or Derived From Tobacco Are Regulated as Drugs, Devices, or Combination Products; Amendments to Regulations Regarding “Intended Uses”; Reopening of the Comment Period
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      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Notice of proposed rulemaking; reopening of the comment period.
      The comment period for the proposed rule published on September 25, 2015 (80 FR 57756) is extended. Submit either electronic or written comments by December 30, 2015.
      21 CFR Parts 201, 801, and 1100