Last month (December 2021) the FDA published draft guidance regarding Digital Health Technologies for Remote Data Acquisition in Clinical Investigations. The guidance document outlines recommendations intended to facilitate the use of Digital Health Technologies (DHTs) in clinical investigations as appropriate for the evaluation of medical products.
In our easy-to-read fact sheet, you can find out more about what the guidance covers, what you need to include in your FDA regulatory submission, as well as some important considerations to bear in mind as you move through the submission process. You can access the free fact sheet by clicking on the Download button below.