ENZYME BLOGAnalyzing the latest developments in regulatory, compliance, and quality

Digital Tech for Clinical Trials May Carry Hefty Compliance Requirements

The FDA’s new draft guidance for the use of digital health technologies (DHTs) for remote data acquisition in clinical trials promises to help advance the market for a wide range of products in the digital health space. However, developers of these products should be aware that their products will be subject to a substantial amount of verification and validation work, along with a considerable load of usability studies.

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