Analysis of FDA’s new 510(k) guidance by the Emergo Group

US FDA publishes insight into 510(k) Substantial Equivalence determination process (MassDevice)
New draft guidance from the US Food and Drug Administration lays out major factors the agency considers when reviewing 510(k) premarket notification applications to make Substantial Equivalence (SE) determinations.
US regulators have issued the new guidance to serve both as a resource for agency reviewers making SE determinations and as a tool for 510(k) applicants to more effectively demonstrate equivalence to predicate devices already on the US market.
The FDA bases its SE determinations on assess...