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1.7.2.1.1 The review system for medical devices

The Medical Device Amendments (MDA) to the Federal Food, Drug, and Cosmetic Act set up a system for Food and Drug Administration (FDA) review of medical devices.213 The statute categorizes medical devices as Class III, Class II, or Class I, depending on the risk they pose to consumers. For Class III devices, the ones that pose the greatest risk, the FDA requires pre-market approval, its most rigorous review. Class III devices that were introduced into interstate commerce before May 28, 1976, however, can be grandfathered in without such rigorous review. Products that are substantially equivalent to grandfathered products can also be grandfathered in.214 Class II and Class I devices are subject to less rigorous FDA review and need not go through pre-market approval.215 When a device consists of both Class III components and Class I or II components that the FDA has reviewed separately, the Third Circuit holds that express preemption must be examined separately for each component.216

Footnotes

  • 213 {199} See Steele v. Dupuy Orthopaedics, Inc., 295 F. Supp. 2d 439 (D.N.J. 2003) (explanation of review system).

  • 214 {200} 21 U.S.C. § 360(f)(1)(A) (“§ 510(k)”).

  • 215 {201} Riegel v. Medtronic, Inc., 552 U.S. 312, 316–317, 128 S. Ct. 999, 169 L. Ed. 2d 892 (2008).

  • 216 Shuker v. Smith & Nephew, P.L.C., 885 F.3d 760 (3d Cir. 2018).