21 C.F.R. § 814.80
General
A device may not be manufactured, packaged, stored, labeled, distributed, or advertised in a manner that is inconsistent with any conditions to approval specified in the PMA approval order for the device.
Notes of Decisions
Cited in 78
cases (7 in the last 5 years), 1993–2025 · leading case: Barbara E. Horn, of the Est. of Daniel Ray Horn, Deceased v. Thoratec Corp., 376 F.3d 163 (3rd Cir. 2004).
Barbara E. Horn, of the Est. of Daniel Ray Horn, Deceased v. Thoratec Corp., 376 F.3d 163 (3rd Cir. 2004). “Similarly, her failure-to-warn claims would require TCI to provide different warnings and instructions from those approved by the FDA.”
Joseph Mink v. Smith & Nephew, Inc., 860 F.3d 1319 (11th Cir. 2017). “And he pointed to device-specific federal requirements he says S&N violated, including the premarket approval specifications for the device, see 21 C.F.R. § 814.80 , as well as a number of other specific federal regulations.”
Walter Shuker v. Smith & Nephew PLC, 885 F.3d 760 (3rd Cir. 2018). “" 21 C.F.R. § 814.80 . To that end, a manufacturer wishing to make "incremental change[s]" that affect the device's safety and effectiveness must submit a supplemental premarket approval application.”
Ramirez v. Medtronic Inc., 961 F. Supp. 2d 977 (D. Ariz. 2013). “§ 331 (a); see also 21 C.F.R. § 814.80 (providing that a “device may not be .”
Gomez v. St. Jude Med. Daig Div. Inc., 442 F.3d 919 (5th Cir. 2006). “, 21 C.F.R. § 814.80 (prohibiting the production or labeling of any device in a manner inconsistent with any conditions of approval specified in the approval order); 21 C.”
Riley v. Cordis Corp., 625 F. Supp. 2d 769 (D. Minnesota 2009). “A Class III device may not be labeled in a manner that is inconsistent with any conditions specified in its PMA, 21 C.F.R. § 814.80 , and once a device has received PMA, a manufacturer generally needs FDA approval before making changes to the labeling that would affect safety or…”
Worthy v. Collagen Corp., 967 S.W.2d 360 (Tex. 1998). “” 21 C.F.R. § 814.80 . A device manufacturer must promptly report to the FDA any malfunctions of a device or any deaths or serious injuries caused by it.”
Caplinger v. Medtronic, Inc., 784 F.3d 1335 (10th Cir. 2015). “§§ 351, 352; see also 21 C.F.R. § 814.80 (forbidding devices to be “manufactured, packaged, stored, labeled, distributed, or advertised in a manner that is inconsistent with any conditions to approval specified in the PMA approval order for the device”).”
Coleman v. Medtronic, Inc., 223 Cal. App. 4th 413 (Cal. Ct. App. 2014). “(§ 331(a); see 21 C.F.R. § 814.80 (2013) [providing that a “device may not be .”
In Re Medtronic, Inc., Sprint Fidelis Leads, 623 F.3d 1200 (8th Cir. 2010). “(internal quotations and citation omitted); see also 21 C.F.R. § 814.80 ("A device may not be manufactured, packaged, stored, labeled, distributed, or advertised in a manner that is inconsistent with any conditions to approval specified in the PMA approval order for the device.”
Gravitt v. Mentor Worldwide, LLC, 289 F. Supp. 3d 877 (E.D. Ill. 2018). “In connection with that approval, and pursuant to its authority under 21 C.F.R. §§ 814.80 and 814.82, the FDA required Mentor to conduct six-post approval studies designed to address issues not raised during the PMA process.”
Beavers-Gabriel v. Medtronic, Inc., 15 F. Supp. 3d 1021 (D. Haw. 2014). “” 21 C.F.R. § 814.80 (emphasis added). The PMA approval letter for the Infuse Device provides that the Infuse Device “is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one level from L4-S1,” and the “Bone…”
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