Link to an amendment published at 82 FR 2217, Jan. 9, 2017.This amendment was delayed until Mar. 21, 2017, at 82 FR 9501, Feb. 7, 2017.This amendment was further delayed until Mar. 19, 2018, at 82 FR 14319, Mar. 20, 2017.This amendment delayed indefinitely at 83 FR 11639, Mar. 16, 2018.The words intended uses or words of similar import in §§ 801.5, 801.119, 801.122, and 1100.5 of this chapter refer to the objective intent of the persons legally responsible for the labeling of an article (or their representatives). The intent may be shown by such persons' expressions, the design or composition of the article, or by the circumstances surrounding the distribution of the article. This objective intent may, for example, be shown by labeling claims, advertising matter, or oral or written statements by such persons or their representatives. Objective intent may be shown, for example, by circumstances in which the article is, with the knowledge of such persons or their representatives, offered or used for a purpose for which it is neither labeled nor advertised; provided, however, that a firm would not be regarded as intending an unapproved new use for a device approved, cleared, granted marketing authorization, or exempted from premarket notification based solely on that firm's knowledge that such device was being prescribed or used by health care providers for such use. The intended uses of an article may change after it has been introduced into interstate commerce by its manufacturer. If, for example, a packer, distributor, or seller intends an article for different uses than those intended by the person from whom he or she received the article, such packer, distributor, or seller is required to supply adequate labeling in accordance with the new intended uses.
[86 FR 41401, Aug. 2, 2021]
Notes of Decisions
Riley v. Cordis Corp., 625 F. Supp. 2d 769 (D. Minnesota 2009).
· cites it 2× “Riley argues that all of his failure-to-warn claims parallel federal law because the implantation of the Cypher stent in him was off-label, and Cordis was required, under 21 C.F.R. § 801.4 , to warn of dangers associated with certain off-label uses.”
Alton v. Medtronic, Inc., 970 F. Supp. 2d 1069 (D. Or. 2013).
· cites it 4× “” 21 C.F.R. § 801.4 . [Such] intent is determined by such persons’ expressions or may be shown by the circumstances surrounding the distribution of the article.”
United States v. Caputo, 288 F. Supp. 2d 912 (N.D. Ill. 2003).
· cites it 4× “) Defendants identify 21 C.F.R. § 801.4 as the apparent source of the FDA’s authority to prohibit manufacturer promotion of off-label uses.”
Caplinger v. Medtronic, Inc., 784 F.3d 1335 (10th Cir. 2015).
· cites it 2× “t misbranding may be proven by, “among other evidence, oral or written statements by [persons legally responsible for the labeling of drugs] or their representatives and the circumstances that the article is, with the knowledge of such persons or their representatives, offered…”
United States ex rel. Modglin v. DJO Global Inc., 48 F. Supp. 3d 1362 (C.D. Cal. 2014).
· cites it 2× “176 In support of their argument that defendants have an affirmative duty to file a PMA supplement, relators cite 21 C.F.R. § 801.4 . 177 This regulation appears to provide some support for their position.”
United States v. Facteau, 89 F.4th 1 (1st Cir. 2023).
· cites it 3× “2, 2021) (codified at 21 C.F.R. § 801.4 ). - 7 - 3. Adulteration, Misbranding, and Off-label Use The FDCA prohibits the "introduction or delivery for introduction into interstate commerce of any .”
Clements v. Sanofi-Aventis, U.S., Inc., 111 F. Supp. 3d 586 (D.N.J. 2015).
· cites it 2× “§ 352®, (n), and (q)0, as well as a related federal regulation ( 21 C.F.R. § 801.4 ). Taken together, those cited provisions list certain conditions under which a medical device may be deemed “misbranded” within the meaning of the FDCA, and prohibit the manufacture, sale and…”
McCormick v. Medtronic, Inc., 101 A.3d 467 (Md. Ct. Spec. App. 2014).
· cites it 2× “(quoting 21 C.F.R. § 801.4 ). In addition, the intended use “can be demonstrated by ‘oral written statements’ ” by the manufacturer or its representatives.”
Ramirez v. Medtronic Inc., 961 F. Supp. 2d 977 (D. Ariz. 2013).
“” 21 C.F.R. § 801.4 . According to the regulation, then, mere awareness of off-label use can potentially result in the creation of a new intended use.”
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