21 U.S.C. § 379v — Safety report disclaimers

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. (June 25, 1938, ch. 675, § 756, as added Pub. L. 105–115, title IV, § 420 , Nov. 21, 1997 , 111 Stat. 2379 .) Statutory Notes and Related Subsidiaries 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 . CFR Title Parts 21 5 , 7 , 10 , 11 , 12 , 13 , 14 , 15 , 16 , 20 , 25

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