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In Brief: FDA 515(i) reclassifications

This article was originally published in The Gray Sheet

Executive Summary

FDA 515(i) reclassifications: Agency plans to downclassify erythropoietin assays and fibrin monomer paracoagulation tests from Class III to Class II in February along with four or five other devices under Sec. 515(i) of the Safe Medical Devices Act of 1990, staffers say. Under the SMDA authority, manufacturers are required to respond to FDA's call for safety and effectiveness data for preamendments Class III devices that have not been subject to calls for premarket approval applications. Data for the devices covered by the upcoming reclassification proposals were due at FDA in August...
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