Thank you for your interest in Digital Health. We look forward to helping you navigate the FDA's current policies on digital health products and providing informal feedback on the possible regulatory status of products in development. Examples of digital health products, not all of which are regulated by the FDA, include software as a medical device (SaMD), mobile medical applications (MMA), software in a medical device (SiMD), and general wellness products.
Guidance documents discussing digital health products may help to answer to your question. To explain how the FDA intends to regulate certain digital health products, including those circumstances in which the FDA does not intend to enforce applicable regulatory requirements for certain low-risk products, the FDA has published several guidance documents. Links to the final guidance documents appear below.
Guidance documents discussing the FDA's position on digital health products:
- Policy for Device Software Functions and Mobile Medical Applications
- General Wellness: Policy for Low Risk Devices
- Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act
- Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices
- Clinical Decision Support Software
September 27, 2022 Update: The FDA has developed a graphic to provide a visual overview of certain policies described in the guidance and examples of non-device CDS functions and device software functions for illustrative purposes. To view the graphic, visit Your Clinical Decision Support Software: Is It a Medical Device?
The FDA has issued the Digital Health Policy Navigator to help stakeholders with digital health policies. This tool guides users through a series of questions based on published digital health policies, to provide general information to help a user assess whether a particular software function meets the device definition and, if so, whether it is the focus of FDA's oversight as a device. The tool directs users to the appropriate policies to learn more.
To make sure you receive the information you need in a timely manner, please review the categories below and send your question directly to the relevant team:
Questions about Medical Device Regulation
- Please send these questions to the Division of Industry and Consumer Education (DICE) at 1-800-638-2041 or DICE@fda.hhs.gov.
- Comprehensive educational content related to medical device regulation, including slide presentations and webcasts, is also available on our Device Advice page.
Questions about an Upcoming Premarket Submission
- Please contact the appropriate review division through a Q-submission. You can learn more about the process for requesting a pre-submission meeting in the Requests for Feedback on Medical Device Submissions guidance document.
- Some example topics for the review division might include clinical study design, nonclinical testing protocols, or cybersecurity considerations specific to a particular device.
Questions about Interpreting Digital Health Guidance
- Please send these questions to the Digital Health Center of Excellence at DigitalHealth@fda.hhs.gov.
- Example questions to send this team might include:
- Can you help me determine whether the FDA would consider my digital health product to be an actively regulated product?
- Can you help me understand the FDA definition of a low-risk product, as referenced in the General Wellness guidance document?