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.