Improving the 510(k) FDA Process for Cardiac Troponin Assays: In Search of Common Ground

[摘要] We met recently with the leadership of the Food and Drug Administration's (FDA's)6 Division of Chemistry and Toxicology Devices to discuss concerns about the heterogeneity of analytical and clinical protocols used in studies for clearance of cardiac troponin assays. We, as experts, are frequently asked to help with the evaluation of new cardiac troponin assays and are aware of variability between the specific protocols used, which are difficult to understand, but which likely reflect differences in the various companies' interpretations of what elements are mandated by the FDA. We advocated to the FDA the use of standardized study protocols to reduce complexity and permit better comparisons among methods and provided suggestions to achieve these goals. Attending from the FDA's Division of Chemistry and Toxicology Devices in the Office of In Vitro Diagnostics and Radiological Health were the Division Director, the Branch Chief of Cardio-Renal Devices, Medical Officers, and Reviewers.Although the FDA seemed supportive, it must be made clear that the opinions expressed here are those of the authors and do not represent those of the FDA. It was our impression that the FDA was in favor of uniform protocols, especially if developed by national organizations; they even expressed a willingness to participate. The FDA indicated, and we concurred, a need to evaluate protocols within the context of the sponsor's specific claims. The FDA leadership stated that it does not mandate the number of participants needed in a study, the specific criteria for diagnosis of acute myocardial infarction (AMI), or approaches used in reference interval studies. Rather, the FDA emphasized that manufacturers should present properly designed and powered studies to support their claims. The FDA indicated that it will provide feedback on study design before study implementation. Our impression was that once a protocol is finalized, the FDA felt …

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