In 2011, the U.S. Food and Drug Administration (FDA) released their draft guidance Applying Human Factors and Usability Engineering to Optimize Medical Device Design.
It provides the FDA’s “current thinking on this topic” and the recommendations “…are intended to improve the usability of devices to reduce use error, injuries from medical devices, and product recalls. The FDA believes that these recommendations will help control current risks and reduce future risks associated with device use” (p. 4).
The draft guidance has generated a lot of interest – and provoked numerous questions – from the medical device community. At the 2013 International Symposium on Human Factors and Ergonomics in Health Care: Advancing the Cause, Ron Kaye, Human Factors Pre-Market Evaluation Team Leader for the FDA, noted that more than 500 comments were submitted to the Agency during the review period.
A recurring question since its release has been “When will the draft guidance be finalized?” It looks like we have our answer.
The FDA has released the CDRH Fiscal Year 2015 (FY2015) Proposed Guidance Development and Focused Retrospective Review of Final Guidance, which includes the draft guidance on their “A-list” (…prioritized device guidance documents that the Agency intends to publish within 12 months of the date this list is published…).
It will be interesting to see if the final guidance is substantially different or not from the draft guidance.