The Evolution of Substantial Equivalence in FDA's Premarket Review of Medical Devices

August 2001

Issue: 56 Food and Drug Law Journal 317--338 (2001).

Although it is doubtful that Congress originally intended it to have such significance, the 510(k) process has become the primary path by which manufacturers shepherd new medical devices to market. Springing from the enigmatic "substantial equivalence" language of the Medical Device Amendments of 1976 (MDA), 510(k)s outnumber premarket approval (PMA) applications by a ratio of 10 to 1. This article traces the evolution of substantial equivalence in the Food and Drug Administration's (FDA's) premarket review of medical devices and examines how FDA's application of this standard impacts medical device manufacturers, consumers, and tort victims. To better understand the origins of this standard, the article begins by examining federal control over medical devices before the MDA and how the amendments transformed the premarket review process. The article continues by recounting how FDA developed the substantial equivalence doctrine in the 1980s and how Congress made some modifications to the scheme in the 1990s. After examining how premarket review of medical devices operates today, the article concludes by suggesting how changes to the current paradigm might benefit public health.


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