Interact with regulators early and often

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

The Value of Interacting
Communication Toolkit

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.

Communication Toolkit

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

Regulatory Engagement Pathways Map for Digital Health Product

Engagement Pathways to Communicate with the U.S. Regulators (FDA – Food and Drug Administration)

Checklist for 513(g) Request

Checklist for Pre-Submission Meeting Preparation

Best Practices to Interacting with the U.S. Regulators (FDA – Food and Drug Administration)

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