FDA Final Guidance Adds Recommendations on DHT Info Needed in Submissions
December 22, 2023 at 03:16 PM EST
The FDA issued final guidance on the use of digital health technologies (DHT) for remote data acquisition in clinical investigations on Dec. 21.
The new guidance finalizes a December 2021 draft guidance and provides recommendations for “ensuring that a DHT is fit-for-purpose (i.e., that the level of validation associated with the DHT is sufficient to support the use, includin... Read More
