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

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.

Join us for the official launch of DiMe’s Integrated Evidence Plans (IEP) resources, designed to help you overcome key challenges in evidence generation and commercial adoption of digital health technologies (DHTs)!

Join us for our launch, “Unlocking impact through investment: Building the business case for digital endpoints,” on Mar. 26 at 11 a.m. ET. Learn how new resources support you in measuring ROI and building your business case for digital endpoints.

Work with DiMe on an upcoming project

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

Identify

Build

Interact