The guidance documents listed here are FDA guidances with Digital Health content and are intended to provide clarity on the FDA's regulation of digital health products.
List of FDA Guidance Documents with Digital Health Content
- Webinar - Content of Premarket Submissions for Device Software Functions - June 12, 2023
- Webinar - Clinical Decision Support Software Final Guidance - October 18, 2022
- Webinar - Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions - Draft Guidance - June 14, 2022
- Webinar - Digital Health Technologies (DHTs) for Remote Data Acquisition Draft Guidance - February 10, 2022
- Webinar - Multiple Function Device Products: Policy and Considerations - September 10, 2020
- Webinar Materials - Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act: Final Guidance (2019)