July 21, 2014 by MassDevice
The Emergo Group Blog provides short updates on quality and regulatory topics that may be of interest to QA/RA professionals in the medical device and IVD industry. No fluff, just straight to the point. We hope you’ll enjoy the content.
By Stewart Eisenhart, Emergo Group
New draft guidance from the US Food and Drug Administration lays out major factors the agency considers when reviewing 510(k) premarket notification applications to make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.