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DiMe Testimonial

Megan Coder, Chief Policy Officer at Digital Therapeutics Alliance

“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.”

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