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In Brief: Device remarketing

This article was originally published in The Gray Sheet

Executive Summary

Device remarketing: Comments on FDA's plans to revise its policies for regulating device remarketers are due by March 23, the agency says in a Dec. 23 Federal Register notice. The notice includes definitions of refurbishers, "as is" remarketers and servicers, and FDA seeks input on whether it should propose the definitions either in guidance or regulation. The definitions all include the criteria that the company does not "significantly change the finished device's performance or safety specifications or intended use." In addition, FDA is reevaluating the application of labeling, manufacturing, reporting and other requirements to remarketers. The agency also is "considering whether to propose rulemaking regarding modified registration, listing, and" good manufacturing practices requirements for remarketers, "or whether to make some or all of these three controls voluntary"...
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