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Highlight Updates The FDA’s narrow preemption regulation

A regulation adopted by the FDA gives a narrow reading to preemption under the Medical Device Amendments. The regulation states that state or local requirements of general applicability are not preempted when they relate to other products in addition to medical devices, and lists UCC warranties and state deceptive practices (UDAP) statutes as examples.241 It also states that state or local requirements are preempted only when the FDA has adopted a specific counterpart regulation or other specific requirements applicable to a particular medical device.242 It provides that state and local requirements that are equal to or substantially identical to federal requirements are not preempted.243 The Supreme Court gave some weight to this regulation in its 1996 Lohr decision.244 In its 2008 Riegel decision, however, it gave the regulation no weight, and its language suggests that it finds the regulation’s distinctions illogical.245


  • 241 {241} 21 C.F.R. § 808.1(d)(1).

  • 242 {242} 21 C.F.R. § 808.1(d). See James v. Diva Int’l, Inc., 803 F. Supp. 2d 945 (S.D. Ind. 2011) (relying in part on FDA’s regulation to deny motion to dismiss).

  • 243 {243} 21 C.F.R. § 808.1(d)(2).

  • 244 {244} Medtronic, Inc. v. Lohr, 518 U.S. 470, 495–501, 116 S. Ct. 2240, 135 L. Ed. 2d 700 (1996).

  • 245 {245} Riegel v. Medtronic, Inc., 552 U.S. 312, 328–329, 128 S. Ct. 999, 169 L. Ed. 2d 892 (2008).