display:none
Generic selectors
Exact matches only
Search in title
Search in content
Post Type Selectors

Interact with regulators early and often

Develop digital health products that best meet your commercial goals and the needs of patients.

The value of digital health regulations

With trust in the emerging digital health products being essential to their adoption, regulatory oversight offers a robust path for digital health product developers to demonstrate the safety and efficacy of their solutions. Regulatory oversight also opens the door to additional reimbursement pathways. However, there is uncertainty among digital health product developers, their clinical partners, and digital health investors. This document illustrates the value of digital health regulations along with 3 illustrative examples.

Value of Regulations for Digital Health Products in the U.S._DiMe_RegPath

Communication Toolkit

Use this toolkit to better understand the formal and informal engagement options and resources to best communicate with FDA.

Stay tuned for more information about DiMe’s Digital Health Regulatory Pathway Work

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.

Sign up to receive our monthly updates

Sign Up

Engage with the dime community on slack

Join Slack

USING A DIME RESOURCE? Share your story

Share A Story

Contact Us

Copyright ©2023 The Digital Medicine Society (DiMe). All Rights Reserved.