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  1. Digital Health Center of Excellence

Digital Health Frequently Asked Questions (FAQs)

Digital health technologies are advancing rapidly, and the Food and Drug Administration (FDA) regulatory landscape is evolving to continue helping developers bring safe, effective, and innovative technologies to market. The FDA encourages digital health developers to contact the Center for Devices and Radiological Health's (CDRH) Digital Health Center of Excellence (DHCoE) throughout the development process with questions about digital health regulatory considerations.

Do you have a Question About Digital Health Policy?

Before contacting us, please review our list of FAQs below and explore the FDA’s many publicly available resources online to help answer your general questions. This will ensure we can provide valuable informal responses to your specific digital health policy questions in a timely manner.

Did you know the FDA has online education tools? Device Advice provides comprehensive regulatory education. Device Advice is CDRH's premier resource that explains medical device laws, regulations, guidances, and policies, across the entire product lifecycle. For more information read Device Advice: Comprehensive Regulatory Assistance.

Frequently Asked Questions (FAQs)

The FAQs below are intended to help you find resources quickly and suggest similar content that may interest you. 

Please email your digital health regulatory questions to DigitalHealth@fda.hhs.gov. We provide informal feedback to stakeholders seeking more information on the FDA’s digital health regulatory considerations. If you have an inquiry that is linked to a specific product, we encourage you to share information such as the product’s intended use, full functionality, and marketing claims you wish to make in your email. 


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