BuckeyeBurro
Starting to get Involved
Hello,
My company is interested in performing an early feasibility study with production prototypes of our upcoming medical device that we plan to release in the US. The device is a secondary display for glucose monitoring (for the sake of discussion, imagine it being an Apple Watch app that shows your glucose reading as a color). This device is conclusively a class II, 510(k)-exempt medical device.
We are interested in gathering early user feedback by providing 10 users (friends within our network) with these devices for two weeks and allowing them to use them as they choose. Specifically, we are hoping to get early feedback that may influence design changes and identify bugs in our app. We do not intend for this to be a formative or summative usability validation, and it likely will not be part of our DHF/MDF. Labeling accompanying the prototypes (e.g., a user manual) will not represent the actual labeling.
I have not yet run into such a study in my career, and I want to better understand the types of things we should consider before such a study (e.g., informed consent and liability waivers). Further, given we are not subject to any pre-market submissions, would this fall under FDA's Early Feasibility Studies Program? Any insight as to what this type of study would be considered and the things our team should look into ahead of such a study would be greatly appreciated!
My company is interested in performing an early feasibility study with production prototypes of our upcoming medical device that we plan to release in the US. The device is a secondary display for glucose monitoring (for the sake of discussion, imagine it being an Apple Watch app that shows your glucose reading as a color). This device is conclusively a class II, 510(k)-exempt medical device.
We are interested in gathering early user feedback by providing 10 users (friends within our network) with these devices for two weeks and allowing them to use them as they choose. Specifically, we are hoping to get early feedback that may influence design changes and identify bugs in our app. We do not intend for this to be a formative or summative usability validation, and it likely will not be part of our DHF/MDF. Labeling accompanying the prototypes (e.g., a user manual) will not represent the actual labeling.
I have not yet run into such a study in my career, and I want to better understand the types of things we should consider before such a study (e.g., informed consent and liability waivers). Further, given we are not subject to any pre-market submissions, would this fall under FDA's Early Feasibility Studies Program? Any insight as to what this type of study would be considered and the things our team should look into ahead of such a study would be greatly appreciated!
