August 26, 2014
By Pamela A. Davol, Clinical and Regulatory Project Manager
Even before the CDRH draft guidance for Human Factors testing was released on June 22, 2011, human factors reviewers at FDA were sending requests for additional information from medical device or pharmaceutical companies who submitted HFE/UE reports that only summarized results from usability validation evaluations of their investigational products to support their marketing submissions. Now more than ever, as medical product usability takes center stage and is frequently the bottle-neck for acquiring marketing approval, manufacturers who only summarize the outcomes of their usability validation study will be met with requests for additional document submission. Such requested information includes (but is not limited to):
…any or all of which may hold-up a regulatory submission for months and significantly delay marketing clearance/approval for months.
Although the HFE/UE is often described as a “summary document,” this report is typically 80 pages (including appendices) for simple drug delivery devices and up to 150+ pages for more complex medical devices or delivery systems. The expectation is that the report will summarize all usability and risk assessment activities throughout the product development cycle. However, when it comes to the usability validation section of the report (Section 6; based on CDRH, Guidance Document: Applying Human Factors and Usability Engineering to Optimize Medical Device Design, June 22, 2011, Appendix A), FDA reviewers require actual data obtained during usability validation testing, including:
The most successful HFE/UE reports are those that meet all required contents. When prepared with advanced knowledge and experience of precisely what the expectations will be from FDA HF usability reviewers at CDRH, CDER or CBER, the review process of the HFE/UE report does not have to be the bottle-neck for submission approvals many manufacturers face today.
Learn more about how Ximedica integrates Human Factors into Medical Device Development and the subsequent documentation collected for submission at our upcoming workshop.