Guidances with Digital Health Content

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.

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List of FDA Guidance Documents with Digital Health Content

Issue Date	Guidance	Guidance Status
01/07/2025	Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations	Draft
12/04/2024	Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions	Final
09/27/2023	Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions	Final
08/11/2023	Off-The-Shelf Software Use in Medical Devices	Final
06/14/2023	Content of Premarket Submissions for Device Software Functions	Final
09/28/2022	Clinical Decision Support Software	Final
12/22/2023	Digital Health Technologies for Remote Data Acquisition in Clinical Investigations	Final
11/04/2020	Multiple Function Device Products: Policy and Considerations	Final
09/27/2019	Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act	Final
09/28/2022	Policy for Device Software Functions and Mobile Medical Applications	Final
09/28/2022	Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices	Final
09/27/2019	General Wellness: Policy for Low Risk Devices	Final
12/20/2017	Medical Device Accessories - Describing Accessories and Classification Pathways	Final
12/08/2017	Software as a Medical Device (SAMD): Clinical Evaluation	Final
10/25/2017	Deciding When to Submit a 510(k) for a Software Change to an Existing Device	Final
09/06/2017	Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices	Final
12/28/2016	Postmarket Management of Cybersecurity in Medical Devices	Final
02/03/2016	Applying Human Factors and Usability Engineering to Medical Devices	Final
08/14/2013	Radio Frequency Wireless Technology in Medical Devices	Final
09/28/2022	Computer-Assisted Detection Devices Applied to Radiology Images and Radiology Device Data - Premarket Notification [510(k)] Submissions	Final
09/28/2022	Clinical Performance Assessment: Considerations for Computer-Assisted Detection Devices Applied to Radiology Images and Radiology Device Data - Premarket Approval (PMA) and Premarket Notification [510(k)] Submissions	Final
03/18/2010	Guidance: Acceptable Media for Electronic Product User Manuals	Final
02/09/2005	Information for Healthcare Organizations about FDA's "Guidance for Industry: Cybersecurity for Networked Medical Devices Containing Off-The-Shelf (OTS) Software"	Final
01/14/2005	Cybersecurity for Networked Medical Devices Containing Off-the-Shelf (OTS) Software	Final

Resources

• Webinar - Draft Guidance: Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations - February 18, 2025
• Webinar - Content of Premarket Submissions for Device Software Functions - July 20, 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)