FDA Seeks Feedback on Using Patient Preference Information in Medical Device Design and Approval
In May, the FDA announced an opportunity to submit feedback on what patients prefer in their medical devices to guide the agency’s regulatory decisions.
The agency has posted a Priority List of areas that particularly need patient input, which includes:
- Understanding how people with diabetes value certain attributes of diabetes devices like interoperability
- Benefit-risk tradeoffs related to treatments for diabetes
- Understanding patient views on apps
- Personal experiences with devices
- User desires to have a product available as soon as possible (vs. doing more clinical trials and having more confirmation of less risk).
The FDA wants feedback on whether the list needs to be changed and any information about existing studies that can address the listed areas. A public docket is now open, with comments due by July 2.
We view this call for feedback as a positive for diabetes technology, since it will allow device manufacturers to measure meaningful patient input like the added value of interoperability and connectivity, user experience and device convenience (e.g., smartphone and Watch bolusing), quality of life and alarms (e.g., sleep, interruptions), time spent on diabetes, and beyond. While these attributes might not directly improve A1C or time-in-range, they are most certainly valued by many people with diabetes and can make an enormous difference in real-world use.
Strong patient-preference data like this could help accelerate the development and approval of much-needed products, too. FDA’s device division has been forward-thinking in approvals and novel pathways like iCGM and ACE Pump, but there remains only one hybrid closed-loop system on the US market (670G) and no basal-bolus decision support for MDI users.
For more background, the FDA has a page on using patient preference information in device submissions.