A digital health technology (DHT) is a system that uses computing platforms, connectivity, software, and/or sensors, for health care and related uses.
This guidance provides recommendations on the use of digital health technologies (DHTs) to acquire data remotely from participants in clinical investigations that evaluate medical products.
DHTs for remote data acquisition in clinical investigations can include hardware and/or software to perform one or more functions. Use of DHTs as recommended in this guidance may improve the efficiency of clinical trials for sponsors, investigators, and other stakeholders and may increase the opportunities for individuals to participate in research and make participation more convenient.
FDA marketing authorization of the DHT may support verification and validation of the DHT if the context of use for the clinical investigation falls within the cleared or approved indications for use
Takeaway:
This guidance outlines recommendations intended to facilitate the use of DHTs in clinical investigations as appropriate for the evaluation of medical products. These recommendations also address some of the information regarding DHTs that sponsors should include in:
- an investigational new drug application (IND)
- an investigational device exemption (IDE) application
- a marketing application
- a Drug Development Tool (DDT) submission
- a Medical Device Development Tool (MDDT) submission
