Findings
There is uncertainty regarding the regulatory acceptability of data collected from wearable devices.
There is a lack of specific regulatory guidance on implementing wearables in clinical trial protocols.
The need for evidence to demonstrate the appropriateness and clinical relevance of new endpoints derived from wearable data.

Recommendations
Identify essential properties of fit-for-purpose wearables and propose evidence needed to support their use.
Extend the FDA’s definition of a PerfO to include unsupervised settings.
Ensure that any wearable device adheres to basic properties important to clinical trials, such as source data control, traceability, and security.
Provide evidence supporting the reliability, validity, and interpretability of data generated by wearable devices.

Regulatory Considerations
Market clearance/certification is not a requirement for device selection in clinical trials if evidentiary considerations are satisfied.
The need for a robust framework for adopting wearables in regulatory trials despite the lack of specific guidance.
The evidence needed to support a device and its endpoint depends on the ultimate use of the endpoint.