21 C.F.R. § 801.6
Medical devices; misleading statements
Among representations in the labeling of a device which render such device misbranded is a false or misleading representation with respect to another device or a drug or food or cosmetic.
Notes of Decisions
Cited in 2
cases, 2012–2018 · leading case: Walter Shuker v. Smith & Nephew PLC, 885 F.3d 760 (3rd Cir. 2018).
Walter Shuker v. Smith & Nephew PLC, 885 F.3d 760 (3rd Cir. 2018). “§§ 331 (b), 352(q), even if such advertising was for the purpose of marketing a separate device, 21 C.F.R. § 801.6 . Second, as to breach, the complaint asserts that, even though the FDA did not approve the R3 metal liner for use with any hip system other than the Birmingham Hip…”
Hawkins v. Medtronic, Inc., 909 F. Supp. 2d 901 (S.D. Ohio 2012). “77 and 21 C.F.R. § 801.6 . (Am. Compl. ¶ 63.) The Sixth Circuit has held that, in the context of investigational devices, claims under Ohio Revised Code § 2307.”
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