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.