Usability Guidance Document Referenced

In an update to the list of recognized standards (Recognition List #43) FDA-CDRH included references to the recent Guidance Document on human factors and usability engineering. The guidance, issued on February 3, 2016, is Applying Human Factors and Usability Engineering to Medical Devices – Guidance for Industry and Food and Drug Administration Staff.

The guidance is listed for ISO 14971:2007, IEC 60601-1-6:2013, IEC 60601-1-8:2006, IEC 62366:2014, IEC 62366-1:2015, and AAMI/ANSI HE75:2009/(R)2013. It also includes any corresponding US versions of international standards.

The list is in the OMBU Library in the Usability Engineering aisle.