Devices

Digital Health Regulatory Science Opportunities

The CDRH Digital Health Center of Excellence has published “Spotlight: Digital Health Regulatory Science Opportunities” highlighting important research areas identified by FDA and external stakeholders. The document describes the current regulatory science areas of interest in digital health for stakeholders to consider.

“Advances in digital health occur rapidly,” CDRH says, “and new areas of interest are likely to arise, prompting new regulatory science research focus areas throughout the ecosystem.”

The document does not initiate a call for proposals or carry funding implications, CDRH says. Rather, it is meant to highlight important scientific research areas identified by internal and external stakeholders.

The areas of interest are divided into three categories: advancing patient engagement, leveraging connectivity, and improving healthcare through software. The topic areas are broken down into near-term and longer-term categories depending on whether there are longer-term efforts that may help to advance the field.

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