U.S. Code » Title 21 » Chapter CHAPTER 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter SUBCHAPTER V— DRUGS AND DEVICES › Part Part A— Drugs and Devices

21 U.S.C. § 360k

State and local requirements respecting devices

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(a) General ruleExcept as provided in subsection (b), no State or political subdivision of a State may establish or continue in effect with respect to a device intended for human use any requirement—(1) which is different from, or in addition to, any requirement applicable under this chapter to the device, and(2) which relates to the safety or effectiveness of the device or to any other matter included in a requirement applicable to the device under this chapter.(b) Exempt requirementsUpon application of a State or a political subdivision thereof, the Secretary may, by regulation promulgated after notice and opportunity for an oral hearing, exempt from subsection (a), under such conditions as may be prescribed in such regulation, a requirement of such State or political subdivision applicable to a device intended for human use if—(1) the requirement is more stringent than a requirement under this chapter which would be applicable to the device if an exemption were not in effect under this subsection; or(2) the requirement—(A) is required by compelling local conditions, and(B) compliance with the requirement would not cause the device to be in violation of any applicable requirement under this chapter.(June 25, 1938, ch. 675, § 521, as added Pub. L. 94–295, § 2, May 28, 1976, 90 Stat. 574.)
Notes of Decisions
Cited in 732 cases (119 in the last 5 years), 1978–2026 · leading case: Walter Shuker v. Smith & Nephew PLC, 885 F.3d 760 (3rd Cir. 2018).
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Walter Shuker v. Smith & Nephew PLC, 885 F.3d 760 (3rd Cir. 2018). · cites it 14× “21 U.S.C. § 360k(a). 2 The statute thus preempts any state requirement that has "the effect of establishing a substantive requirement for [the] specific device" in question that relates to safety, effectiveness, or "any other matter" that forms a federal requirement, so long as…”
Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996). · cites it 12× “) Medtronic removed the case to Federal District Court, where it filed a motion for summary judgment arguing that both the negligence and strict-liability claims were preempted by 21 U. S. C. § 360k(a). That section, which is at the core of the dispute between the parties in…”
Blunt v. Medtronic, Inc., 2009 WI 16 (Wis. 2009). · cites it 40× “Both the circuit court and the court of appeals agreed that the express preemption provision of the 1976 Medical Device Amendments to the Federal Food, Drug and Cosmetic Act, specifically 21 U.S.C. § 360k(a) (2000), [3] preempted the negligence, strict liability and loss of…”
Riegel v. Medtronic, Inc., 552 U.S. 312 (2008). · cites it 8× “We consider whether the pre-emption clause enacted in the Medical Device Amendments of 1976, 21 U.S.C. § 360k, bars common-law claims challenging the safety and effectiveness of a medical device given premarket approval by the Food and Drug Administration (FDA).”
Wyeth v. Levine, 555 U.S. 555 (2009). · cites it 6× “21 U.S.C. § 360k (authorizing the FDA to determine the scope of the Medical Devices Amendments' pre-emption clause), [9] the question is what weight we should accord the FDA's opinion.”
Aaron v. Medtronic, Inc., 209 F. Supp. 3d 994 (S.D. Ohio 2016). · cites it 10× “Express Preemption The MDA’s preemption clause, 21 U.S.C. § 360k(a), prohibits the use of state *1002 law to enforce any requirement that is “different from, or in addition to” requirements imposed by the FDA.”
Altria Grp., Inc. v. Good, 555 U.S. 70 (2008). · cites it 5× “, at 14) (quoting 21 U. S. C. §360k(a); emphasis deleted). The catheter at issue in Riegel had received premarket approval from the Food and Drug Administration (FDA).”
McLaughlin v. Bayer Corp., 172 F. Supp. 3d 804 (E.D. Pa. 2016). · cites it 7× “21 U.S.C. § 360k(a). In the controlling case of Riegel v.”
Joseph Mink v. Smith & Nephew, Inc., 860 F.3d 1319 (11th Cir. 2017). · cites it 5× “They are 21 U.S.C. § 360k(a), the “express preemption” provision, and 21 U.”
Barbara E. Horn, of the Est. of Daniel Ray Horn, Deceased v. Thoratec Corp., 376 F.3d 163 (3rd Cir. 2004). · cites it 7× “(hereinafter “TCI” 1 ), based on its determination that Horn’s claims against TCI are preempted by the express preemption provision in the Food Drug and Cosmetic Act (the “Act”), 21 U.S.C. § 360k(a). 2 We affirm. I. TCI manufactured and distributed the left ventricular assist…”
Barbara Mitchell & Gregory Mitchell v. Collagen Corp., 67 F.3d 1268 (7th Cir. 1995). · cites it 18× “§ 360k(a), that provides: Except as provided in subsection (b) of this section [not relevant in this ease], no State or political subdivision of a State may establish or continue in effect with respect to a device intended for human use any requirement— (1) which is different…”
Bausch v. Stryker Corp., 630 F.3d 546 (7th Cir. 2010). · cites it 4× “Express Preemption — The Limited Scope of 21 U.S.C. § 360k Defendants’ hip implants are so important to patients’ health that they are treated as “Class III Medical Devices” under the federal Food, Drug, and Cosmetic Act.”
Show all 732 citing cases →
— 21 U.S.C. § 360k(a) — 569 cases
Walter Shuker v. Smith & Nephew PLC, 885 F.3d 760 (3rd Cir. 2018). “21 U.S.C. § 360k(a). 2 The statute thus preempts any state requirement that has "the effect of establishing a substantive requirement for [the] specific device" in question that relates to safety, effectiveness, or "any other matter" that forms a federal requirement, so long as…”
Blunt v. Medtronic, Inc., 2009 WI 16 (Wis. 2009). “Both the circuit court and the court of appeals agreed that the express preemption provision of the 1976 Medical Device Amendments to the Federal Food, Drug and Cosmetic Act, specifically 21 U.S.C. § 360k(a) (2000), [3] preempted the negligence, strict liability and loss of…”
Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996). “) Medtronic removed the case to Federal District Court, where it filed a motion for summary judgment arguing that both the negligence and strict-liability claims were preempted by 21 U. S. C. § 360k(a). That section, which is at the core of the dispute between the parties in…”
Aaron v. Medtronic, Inc., 209 F. Supp. 3d 994 (S.D. Ohio 2016). “Express Preemption The MDA’s preemption clause, 21 U.S.C. § 360k(a), prohibits the use of state *1002 law to enforce any requirement that is “different from, or in addition to” requirements imposed by the FDA.”
Wyeth v. Levine, 555 U.S. 555 (2009). “21 U.S.C. § 360k (authorizing the FDA to determine the scope of the Medical Devices Amendments' pre-emption clause), [9] the question is what weight we should accord the FDA's opinion.”
— 21 U.S.C. § 360k(a)(1) — 57 cases
Walter Shuker v. Smith & Nephew PLC, 885 F.3d 760 (3rd Cir. 2018). “21 U.S.C. § 360k(a). 2 The statute thus preempts any state requirement that has "the effect of establishing a substantive requirement for [the] specific device" in question that relates to safety, effectiveness, or "any other matter" that forms a federal requirement, so long as…”
Altria Grp., Inc. v. Good, 555 U.S. 70 (2008). “, at 14) (quoting 21 U. S. C. §360k(a); emphasis deleted). The catheter at issue in Riegel had received premarket approval from the Food and Drug Administration (FDA).”
Conklin Et Ux v. Medtronic Inc, 431 P.3d 571 (Ariz. 2018).
Sherry Walker v. Medtronic, Inc., 670 F.3d 569 (4th Cir. 2012).
Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996). “) Medtronic removed the case to Federal District Court, where it filed a motion for summary judgment arguing that both the negligence and strict-liability claims were preempted by 21 U. S. C. § 360k(a). That section, which is at the core of the dispute between the parties in…”
— 21 U.S.C. § 360k(a)(2) — 13 cases
Walter Shuker v. Smith & Nephew PLC, 885 F.3d 760 (3rd Cir. 2018). “21 U.S.C. § 360k(a). 2 The statute thus preempts any state requirement that has "the effect of establishing a substantive requirement for [the] specific device" in question that relates to safety, effectiveness, or "any other matter" that forms a federal requirement, so long as…”
Riley v. Cordis Corp., 625 F. Supp. 2d 769 (D. Minnesota 2009).
prod.liab.rep. (Cch) P 14,260 Lora Lohr, Michael Lohr, Her Husband v. Medtronic, Inc., a Foreign Corp., 56 F.3d 1335 (11th Cir. 1995).
Barbara Mitchell & Gregory Mitchell v. Collagen Corp., 67 F.3d 1268 (7th Cir. 1995). “§ 360k(a), that provides: Except as provided in subsection (b) of this section [not relevant in this ease], no State or political subdivision of a State may establish or continue in effect with respect to a device intended for human use any requirement— (1) which is different…”
Sciortino v. Pepsico, Inc., 108 F. Supp. 3d 780 (N.D. Cal. 2015).
— 21 U.S.C. § 360k(a)(MDA) — 1 case
Etcheverry v. Tri-Ag Serv., Inc., 993 P.2d 366 (Cal. 2000).
— 21 U.S.C. § 360k(a)(l) — 49 cases
McLaughlin v. Bayer Corp., 172 F. Supp. 3d 804 (E.D. Pa. 2016). “21 U.S.C. § 360k(a). In the controlling case of Riegel v.”
Altria Grp., Inc. v. Good, 555 U.S. 70 (2008). “, at 14) (quoting 21 U. S. C. §360k(a); emphasis deleted). The catheter at issue in Riegel had received premarket approval from the Food and Drug Administration (FDA).”
Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996). “) Medtronic removed the case to Federal District Court, where it filed a motion for summary judgment arguing that both the negligence and strict-liability claims were preempted by 21 U. S. C. § 360k(a). That section, which is at the core of the dispute between the parties in…”
Elizabeth & Clifford Kemp v. Medtronic, Inc., 231 F.3d 216 (6th Cir. 2000).
Alton Bass v. Stryker Corp., 669 F.3d 501 (5th Cir. 2012).
— 21 U.S.C. § 360k(a)(í) — 1 case
McLaughlin v. Bayer Corp., 172 F. Supp. 3d 804 (E.D. Pa. 2016). “21 U.S.C. § 360k(a). In the controlling case of Riegel v.”
— 21 U.S.C. § 360k(b) — 36 cases
Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996). “) Medtronic removed the case to Federal District Court, where it filed a motion for summary judgment arguing that both the negligence and strict-liability claims were preempted by 21 U. S. C. § 360k(a). That section, which is at the core of the dispute between the parties in…”
Walter Shuker v. Smith & Nephew PLC, 885 F.3d 760 (3rd Cir. 2018). “21 U.S.C. § 360k(a). 2 The statute thus preempts any state requirement that has "the effect of establishing a substantive requirement for [the] specific device" in question that relates to safety, effectiveness, or "any other matter" that forms a federal requirement, so long as…”
Riegel v. Medtronic, Inc., 451 F.3d 104 (2d Cir. 2006).
Talbott v. C.R. Bard, Inc., 865 F. Supp. 37 (D. Mass. 1994).
H.R. ex rel. Reuter v. Medtronic, Inc., 996 F. Supp. 2d 671 (S.D. Ohio 2014).
— 21 U.S.C. § 360k(c)(1) — 1 case
Goldsmith v. Mentor Corp. (D.N.H. 1995).
— 21 U.S.C. § 360k(l) — 1 case
Duggan v. Medtronic, Inc., 840 F. Supp. 2d 466 (D. Mass. 2012).
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