Regulatory Considerations for Human Factors Studies in Dialysis Devices

Roundtable Recording

Many innovators in the growing dialysis device space find that conducting human factors studies can be challenging and that there is a need for a venue to better understand the regulatory perspective on human factors in dialysis devices.

This public roundtable meeting provided a venue for the US Food and Drug Administration's Centers for Devices and Radiological Health's Human Factors and Dialysis teams to interact with industry around pre-competitive and product agnostic questions about the conduct of human factors studies in dialysis devices.

The meeting agenda was:

1. Opening Remarks
2. The FDA Perspective on Human Factors Studies for Dialysis Devices - Tania Reina, Assistant Director, Human Factors Team
3. Q&A on Technical Topics and the Conduct of Human Factors Studies

If you have any questions about KHI or this event, please contact ASN Artificial Kidney Product Specialist Zach Cahill at zcahill@asn-online.org.