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# CDRH Seeing Patient Preference Benefits: Shuren
- URL: https://www.fdaweb.com/cdrh-seeing-patient-preference-benefits-shuren/
- Published: 2017-09-26T12:00:00.000Z
- Updated: 2026-09-14T22:52:40.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5139708

CDRH director **Jeffrey Shuren** and two other Center executives say they have seen increasing evidence of the benefits of soliciting patient feedback through the Patient Preference Initiatives that was launched in 2015\. Writing in an *FDA Voice* [article](https://blogs.fda.gov/fdavoice/index.php/2017/09/how-patient-preferences-contribute-to-regulatory-decisions-for-medical-devices/?ref=fdaweb.com), Shuren and his colleagues say that in August the Center cleared an expanded indication for a home hemodialysis machine so it could be used without a care partner being present.

After patient advocates argued at a 2015 public meeting that the care partner requirement effectively ruled out home treatment for patients who live alone or could not afford to hire a care partner, CDRH partnered with NxStage, a medical device developer, on a patient-centric approach to assess how much risk dialysis patients could accept. Data from a survey “helped inform the review of NxStage System One’s expanded indication that allows for home hemodialysis without the presence of a care partner,” the FDAers write.

The article also discusses the collection of qualitative feedback from patients that enhanced the safety of the Dexcom G5 continuous glucose monitoring system and the Animas Vibe System, a continuous glucose monitor with an insulin pump, for children. Based on the feedback, the authors say, FDA worked with the company to develop additional risk mitigation strategies that included a lockout feature to prevent unintended boluses by young children playing with the insulin pump.

“We invite companies to start a conversation with FDA about using patient preference information to support your submission,” the article concludes. One opportunity to gain more information would be the 12/7-8 patient preference initiative meeting it says.