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MDR REVISION LIKELY TO SIMPLIFY REGULATORY BURDEN ON INDUSTRY, FDA STAFFERS INDICATE; BURLINGTON RESURRECTS IDEA OF "SENTINEL" REPORTING SYSTEM

This article was originally published in The Gray Sheet

Executive Summary

FDA's Center for Devices and Radiological Health is reexamining its proposed Medical Device Reporting regulations in an effort to minimize the regulatory burden on manufacturers, distributors and users, according to staffers.

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