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Industry Experiences Engaging with the FDA

In August 2023, DiMe released the Digital Health Industry Regulatory Needs Assessment. In response to this feedback, FDA is keen to learn more from industry, specifically related to:

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    Case studies that capture interactions, decisions, or approaches that led to companies’ success in bringing digital health innovation to market via FDA pathways.

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    Insights from companies that are currently undergoing or planning to participate in an FDA review process.

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    Lessons FDA can capture and learn from regarding experiences where the path to market for a digital health technology has not been smooth. 

All DiMe community members are invited to participate in this process by Tuesday, November 21, 2023.

Case study responses will be shared with the FDA to inform and educate agency leaders. To preserve anonymity, companies have the option of de-identifying each case study (i.e., removing company, product, other identifying information).

DiMe will also produce public-facing case study summaries with company permission.

Submissions will be accepted until: Tuesday, November 21, 2023.

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