FDA Guidance: Adaptive Designs for Medical Device Clinical Studies
The FDA released this guidance on Adaptive Designs for medical devices in clinical trials. An adaptive design for a medical device clinical study is defined as a clinical study
design that allows for prospectively planned modifications based on accumulating study data without undermining the study’s integrity and validity.
If you are developing a mobile medical device or mhealth application that is FDA Regulated, this guidance may assist you in designing your protocol.