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Good regulatory strategy is good business strategy

Build a fit-for-purpose regulatory strategy for better commercial decision-making and success.

Develop Your Regulatory Strategy

A comprehensive regulatory strategy is critical for the success of digital health products. Now that you’ve identified your appropriate pathway, use these toolkits to carefully plan and implement a low-risk, successful regulatory review process that integrate into your overall business plan.

U.S. Digital Health Regulatory Pathways Toolkits


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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