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.

Identify
Build
Interact

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.

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Catalog of Regulatory Pathway Resources

RegPath Decision Tool

U.S. Regulatory Pathways Flowchart

Library of Digital Health Regulations

Develop Your Regulatory Strategy

Digital Health Product Classification Toolkit

U.S. Digital Health Regulatory Pathways Toolkits

510(k) Pathway

De Novo

Premarket Approval (PMA

Humanitarian Device Exemption (HDE)

The value of digital health regulations

Communication Toolkit

Glossary