Adequate directions for use means directions under which the layman can use a device safely and for the purposes for which it is intended. Section 801.4 defines intended use. Directions for use may be inadequate because, among other reasons, of omission, in whole or in part, or incorrect specification of:
(a) Statements of all conditions, purposes, or uses for which such device is intended, including conditions, purposes, or uses for which it is prescribed, recommended, or suggested in its oral, written, printed, or graphic advertising, and conditions, purposes, or uses for which the device is commonly used; except that such statements shall not refer to conditions, uses, or purposes for which the device can be safely used only under the supervision of a practitioner licensed by law and for which it is advertised solely to such practitioner.
(b) Quantity of dose, including usual quantities for each of the uses for which it is intended and usual quantities for persons of different ages and different physical conditions.
(c) Frequency of administration or application.
(d) Duration of administration or application.
(e) Time of administration or application, in relation to time of meals, time of onset of symptoms, or other time factors.
(f) Route or method of administration or application.
(g) Preparation for use, i.e., adjustment of temperature, or other manipulation or process.
Notes of Decisions
Caplinger v. Medtronic, Inc., 784 F.3d 1335 (10th Cir. 2015).
· cites it 8× “§ 352 and 21 C.F.R. § 801.5 . Through the combined effect of these provisions, a device’s warning label must not be “false or misleading in any particular,” 21 U.”
Kubicki ex rel. Kubicki v. Medtronic, Inc., 293 F. Supp. 3d 129 (D.C. Cir. 2018).
· cites it 3× “§ 803 , and to adhere to certain standards with respect to the product's labeling and use instructions, see 21 C.F.R. §§ 801.5 , 801.15. Furthermore, as proof that the MMT-522 Pump violates these particular federal standards, Plaintiffs cite the 2013 Warning Letter that…”
Alton v. Medtronic, Inc., 970 F. Supp. 2d 1069 (D. Or. 2013).
· cites it 4× “” 21 C.F.R. § 801.5 . “Directions for use may be inadequate because, among other reasons, of omission, in whole or in part, or incorrect specification of .”
Ormco Corp. v. Align Tech., 463 F.3d 1299 (Fed. Cir. 2006).
“”); 21 C.F.R. § 801.5 (2005) (defining "adequate directions for use”).”
Weinstat v. Dentsply Int'l, Inc., 70 U.C.C. Rep. Serv. 2d (West) 689 (Cal. Ct. App. 2010).
“” ( 21 C.F.R. § 801.5 (2009).) By definition, “adequate directions for use” cannot be prepared for prescription devices such as the Cavitron, because these devices must be used under the supervision of a licensed practitioner.”
Patricia A. Murray Dental Corp. v. Dentsply Int'l, Inc., 227 Cal. Rptr. 3d 862 (Cal. Ct. App. 5th 2018).
“However, such devices will escape the deemed designation of being 'misbranded' where, among other conditions, '[l]abeling on or within the package from which the device is to be dispensed bears information for use, including indications, effects, routes, methods, and frequency…”
Riley v. Cordis Corp., 625 F. Supp. 2d 769 (D. Minnesota 2009).
“, 21 C.F.R § 801.5, and § 801.4 defines the meaning of “intended uses” for the purpose of those regulations.”
Ramirez v. Medtronic Inc., 961 F. Supp. 2d 977 (D. Ariz. 2013).
“§ 352 (f), which FDA regulations define as "directions under which the layman can use a device safely and for the purposes for which it is intended," 21 C.F.R. § 801.5 (emphasis added). The FDA then defines intended use by reference to "the objective intent of the persons…”
Schouest v. Medtronic, Inc., 13 F. Supp. 3d 692 (S.D. Tex. 2014).
“” 21 C.F.R. § 801.5 . A device’s intended use is determined by “the objective intent of the persons legally responsible for the labeling of devices,” and can be demonstrated by “oral or written statements by such persons or their representatives.”
United States Ex Rel. Nowak v. Medtronic, Inc., 806 F. Supp. 2d 310 (D. Mass. 2011).
“§ 352 (f); 21 C.F.R. § 801.5 ; 21 C.F.R. § 807.97 . These limited indications must be listed on the label, and a manufacturer may only promote a device for cleared or approved indications.”
Thorn v. Medtronic Sofamor Danek, USA, Inc., 81 F. Supp. 3d 619 (W.D. Mich. 2015).
“[statements of all conditions, purposes, or uses for which such device is intended,” 21 C.F.R. § 801.5 (a), and whether a particular use is intended may be inferred from, inter alia, the manufacturer’s statements in promotion of the device and its applications, 21 C.”
McCormick v. Medtronic, Inc., 101 A.3d 467 (Md. Ct. Spec. App. 2014).
“3d at 701 (quoting 21 C.F.R. § 801.5 ). “A device’s intended use is *516 determined by ‘the objective intent of the persons legally responsible for the labeling of devices’ ” — ie.”
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