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In Brief: Medical device reporting

This article was originally published in The Gray Sheet

Executive Summary

Medical device reporting: FDA stays effective date of certain portions of the annual baseline reporting requirement of the agency's December 1995 final manufacturer MDR rule. The stay, published in the July 31 Federal Register, applies to the number of devices manufactured, distributed or in use (so-called "denominator data"), which FDA had intended to use in determining the prevalence of adverse events. The agency is issuing the stay "until further notice" in response to device industry concerns about the provision. FDA will explore mechanisms for obtaining denominator data via a small-scale pilot project slated to begin this fall ("The Gray Sheet" July 15, p. 10). The remaining portions of the MDR rule became effective as scheduled July 31...

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