FDA’s 510(k) Review is a Powerful Regulatory Tool, But a Better Public 510(k) Database is Needed to Improve the Predictability of Substantial Equivalence Review

FDA’s 510(k) review is based upon the concept of substantial equivalence.  This approach has been much criticized, but in a new article published in the Food and Drug Law Journal and authored by Hyman, Phelps & McNamara, P.C. Director Jeffrey K. Shapiro, Mr. Shapiro concludes that substantial equivalence review is a powerful regulatory tool allowing FDA to ensure that the broad range of moderate risk devices reach the market based upon a reasonable assurance of safety and effectiveness. 

The article, titled “Substantial Equivalence Premarket Review: the Right Approach for Most Medical Devices,” 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 (see our previous post here), and rebuts a published study finding that substantial equivalence review results in a disproportionate share of serious recalls.  The article argues that a better public 510(k) database is needed to improve the predictability of substantial equivalence review.  Mr. Shapiro concludes by calling for targeted reform of a basically sound system rather than wholesale condemnation as critics have suggested.