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Catalog of Regulatory Pathway Resources

The DiMe Digital Health Regulatory Pathways team has developed three interactive toolkits and a glossary to aid your understanding of federal regulatory pathways to make better decisions, faster, in digital healthcare.


Use the RegPath tool and other resources to navigate and identify your regulatory pathway.


Create and integrate a fit-for-purpose regulatory strategy into your business plan for commercial success.


Ongoing, interact with regulators to develop digital health products that best meet your goals and patients’ needs.

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Help streamline the path to regulatory and commercial success to optimize health outcomes for the greatest number of patients

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