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US Regulatory Reads, July 2018: 510(k) Pushback, Open Payments And Quality Efforts

Executive Summary

Device-makers aren't particularly impressed with US FDA's alternative 510(k) pathway proposal, we reported in Medtech Insight's most popular US regulatory/policy story last month. Also: a look at "Open Payments" data, quality concepts, and pre-market submissions advice in a new Medtech Tips feature series.

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