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Digital Health Regulatory Pathways Explained

Evidence-based digital health tools are critical in driving toward trustworthy products that benefit patients. And regulatory approval is key to truly evidence-based medical products – there’s no way around it.

Regulations don’t have to be daunting. This set of resources will make it easier for you to know which pathways exist if you need them, and how to pursue them so you can go to market faster. You can save time, money, and resources just by figuring out the right regulatory pathway for your products.

Identify

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

Build

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

Interact

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

Project Partners

We are proud to be working alongside the following industry leaders and regulators, including the FDA, to create new regulatory science resources for the field.



See how others are building regulatory strategies

“The digital health industry is a heterogeneous, innovative, and dynamic sector. More importantly, it is continuously changing. Regulatory processes aren’t the limiting factor for digital innovation. Rather an optimal regulatory strategy is a critical part of successful product and business strategy.”

Smit Patel, Associate Director at Digital Medicine Society
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“Across the ecosystem, there is confusion and apprehension about the regulation of health technology products. The RegPath tool is unique because it provides a clear roadmap for innovators to successfully navigate the complex regulatory landscape in the U.S.”

René Quashie, Vice President, Digital Health at the Consumer Technology Association
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“Digital therapeutics (DTx) use software to directly treat, manage, and prevent diseases, and are therefore subject to regulatory oversight to support product claims of risk, efficacy, and intended use. Over the last ten years, FDA’s CDRH division has diligently worked with manufacturers to assess and validate DTx products. These new resources – developed in partnership between FDA and industry leaders – provide further clarity on these critical regulatory pathways.”

Megan Coder, Chief Policy Officer at Digital Therapeutics Alliance
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“We believe these resources will help digital health innovators leverage new technologies to advance more accessible and equitable care. We’re proud to have worked with DiMe and other leading digital health innovators to develop unprecedented resources that can support the innovation ecosystem, speed commercial success, and create more comfort for end users.”

Linda Peters, Vice President of Quality, Regulatory & Safety, Health at Google
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With the increasing role of software-based medical products, they are becoming ubiquitous and an important part of the fabric of technological advancements in healthcare. As a leader in bringing digital health products [particularly Software as a Medical Device (SaMD)] into a traditional drug-focused life sciences industry, it is more important an ever to collaborate and showcase SaMD development and its regulatory implications. Having various types of tools like the ones by DiMe’s RegPath will not only foster innovation in the field of SaMD, but will help thrive!”

Katie Chowdhury Director at Global Regulatory Affairs | Medical Device Team | Digital Health, Emerging Tech and Combination Products at AbbVie
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“We need to flip the script and see regulatory strategy become a differentiator for digital health solution providers. As we anticipate a tightening of funding for digital innovators, the importance of selecting optimal regulatory pathways for individual products and product portfolios becomes critically important to ensure market access, trust, and adoption.”

Jennifer Goldsack, CEO at Digital Medicine Society
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    Using a Regulatory Pathway tool? Share your story today

    We want to hear from you! Tell us how you’re using any of our Regulatory Pathway tools across health care and research and we’ll publish a case study about your work.


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