The U.S. Food and Drug Administration has released a draft guidance focused on using digital health technologies to acquire data remotely from participants in clinical investigations of medical products.
The draft guidance touched on regulatory considerations, noting that DHTs used in clinical investigations of medical products would usually be exempt from applicable requirements to obtain marketing authorization and other device requirements.
It also outlined considerations for study sponsors when using digital health tools in this fashion. The considerations included:
- Technology selection
- Verification, validation and usability of the technology
- Using tools to collect data for clinical endpoints
- Technology risks
- Record protection and retention