Human Factors Guidance Listed in FDA 2016 Priorities

The FDA has released the CDRH Fiscal Year 2016 (FY 2016) Proposed Guidance Development and Focused Retrospective Review of Final Guidance.

In it they included Applying Human Factors & Usability Engineering to Optimize Medical Device Design on their “A-list” (…a list of prioritized device guidance documents that the Agency intends to publish within 12 months of the date this list is published…).

It should be noted that the draft guidance was also on the A-list for FY 2015.  I’ll be interested to see if the final guidance is published this year and whether it is substantially different or not from the draft guidance.