1. LawStack
  2. Title 21 - Food and Drugs
  3. Chapter I - FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
  4. Subchapter H - MEDICAL DEVICES
  5. Part 801 - LABELING
  6. Subpart D - Exemptions From Adequate Directions for Use
  7. 21 CFR § 801.119
21 CFR § 801.119
In vitro diagnostic products
June 25, 2020
CFR

A product intended for use in the diagnosis of disease and which is an in vitro diagnostic product as defined in §809.3(a) of this chapter shall be deemed to be in compliance with the requirements of this part and section 502(f)(1) of the Federal Food, Drug, and Cosmetic Act if it meets the requirements of subpart B of this part and the requirements of §809.10 of this chapter.

[78 FR 58820, Sept. 24, 2013]

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§ 801.116 Medical devices having commonly known directions
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§ 801.122 Medical devices for processing, repacking, or manufacturing

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