White Paper

What Does the New FDA DHT Guidance Mean?

A Practical Guide for Sponsors


In December 2021, the FDA released its first guidance specific to the use of digital health technologies (DHTs). This marked an important milestone, signifying willingness from regulators to adopt new digital clinical measurements. In this ActiGraph white paper, we've synthesized the FDA's guidance into a practical, actionable resource to help sponsors, particularly those new to DHTs, maximize their value in clinical investigations.

What You'll Learn

  • What the regulators expect in a submission
  • What to look for in selecting the right DHT
  • Steps needed to ensure the DHT is fit for purpose
  • How to operationalize DHTs in clinical trials
  • Considerations to evaluate clinical endpoints from DHT data




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