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In Brief: MDR certification

This article was originally published in The Gray Sheet

Executive Summary

MDR certification: FDA sets May 19 as the effective date for manufacturer and distributor annual certification requirements under the agency's medical device reporting regulation, according to a final rule published in the March 20 Federal Register. The rule codifies language offered by FDA in a July 1996 proposed rule that a firm's statement certifying the number of MDR reports submitted to the agency in a given year (or that no MDRs had been submitted) be signed by a company official "with oversight responsibilities for, and knowledge of, the firm's MDR reporting system," and the company "may designate more than one certifying official, each of whom will sign a certification statement pertaining to their respective identified component(s) or sites(s)" ("The Gray Sheet" July 22, 1996, I&W-1). The only modification to the language in the final rule is the addition of a statement that the certification is being made "to the best of [the designated official's] knowledge and belief." As outlined in the December 1995 final MDR rule, certification was to be made by the company president or CEO. FDA stayed the certification requirement, which was to have gone into effect with the entire MDR rule on July 31, 1996, due to industry concerns of potential liability for inadvertent reporting errors...
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