2018 US Code
Title 21 - Food and Drugs
Chapter 9 - Federal Food, Drug, and Cosmetic Act
Subchapter VII - General Authority
Part G - Safety Reports
Sec. 379v - Safety report disclaimers
| 21 U.S.C. § 379v (2018) |
| §379v. Safety report disclaimers |
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With respect to any entity that submits or is required to submit a safety report or other information in connection with the safety of a product (including a product that is a food, drug, device, dietary supplement, or cosmetic) under this chapter (and any release by the Secretary of that report or information), such report or information shall not be construed to reflect necessarily a conclusion by the entity or the Secretary that the report or information constitutes an admission that the product involved malfunctioned, caused or contributed to an adverse experience, or otherwise caused or contributed to a death, serious injury, or serious illness. Such an entity need not admit, and may deny, that the report or information submitted by the entity constitutes an admission that the product involved malfunctioned, caused or contributed to an adverse experience, or caused or contributed to a death, serious injury, or serious illness. |
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(June 25, 1938, ch. 675, §756, as added Pub. L. 105–115, title IV, §420, Nov. 21, 1997, 111 Stat. 2379.) |
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EFFECTIVE DATE
Section effective 90 days after Nov. 21, 1997, except as otherwise provided, see section 501 of Pub. L. 105–115, set out as an Effective Date of 1997 Amendment note under section 321 of this title. |
| United States Code, 2018 Edition, Title 21 - FOOD AND DRUGS |
| Bills and Statutes |
| United States Code |
| Y 1.2/5: |
| Title 21 - FOOD AND DRUGS CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT SUBCHAPTER VII - GENERAL AUTHORITY Part G - Safety Reports Sec. 379v - Safety report disclaimers |
| section 379v |
| 2018 |
| January 14, 2019 |
| No |
| standard |
| 111 Stat. 2379 |
| Public Law 105-115 |
