title: Substantial Equivalence Premarket Review: the Right Approach for Most Medical Devices.
abstract: The Food and Drug Administration (FDA)'s 510(k) program based upon substantial equivalence review is by far the dominant pathway to market among medical devices requiring premarket review. Substantial equivalence review has been much criticized, but this article concludes that it is a powerful regulatory tool allowing FDA to appropriately ensure that the broad range of moderate risk devices meet the statutory requirement of reasonable assurance of safety and effectiveness. The article examines substantial equivalence review in detail, looking at its historical development, the operative legal framework, the specific decision steps FDA follows to reach a substantial equivalence determination, and the strengths of the system in fostering efficiency, predictability, and adaptability in the premarket review of medical devices. The article rebuts the Institute of Medicine's call to scrap substantial equivalence review, and rebuts another critic's finding that substantial equivalence review results in a disproportionate share of serious recalls. The article suggests that a better public 510(k) database would improve the predictability of substantial equivalence review. The article concludes by calling for targeted reform of a basically sound system rather than wholesale condemnation as critics have suggested.
authors.forename: Jeffrey K
authors.initials: JK
authors.lastname: Shapiro
mesh_terms: D018795:Device Approval / Q000331:legislation & jurisprudence*; D004869:Equipment Safety / Q000592:standards; D006801:Humans; D014481:United States; D014486:United States Food and Drug Administration