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.

Please note that the 21st Century Cures Act (12/13/2016) amended the definition of "device" in the Federal Food, Drug, and Cosmetic Act to exclude certain software functions from FDA regulation.

If you have questions about how the 21st Century Cures Act affects your products, or if you have comments on how the FDA should regulate medical software, please email digitalhealth@fda.hhs.gov.

List of FDA Guidance Documents with Digital Health Content

Guidance	Issue Date	Guidance Status
Digital Health Technologies for Remote Data Acquisition in Clinical Investigations	December 23, 2021	Draft
Content of Premarket Submissions for Device Software Functions	November 4, 2021	Draft
Multiple Function Device Products: Policy and Considerations	July 29, 2020	Final
Clinical Decision Support Software	September 27, 2019	Draft
Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act	September 27, 2019	Final
Policy for Device Software Functions and Mobile Medical Applications	September 27, 2019	Final
Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices	September 27, 2019	Final
General Wellness: Policy for Low Risk Devices	September 27, 2019	Final
Off-The-Shelf Software Use in Medical Devices	September 27, 2019	Final
Content of Premarket Submissions for Management of Cybersecurity in Medical Devices	October 18, 2018	Draft
Content of Premarket Submissions for Management of Cybersecurity in Medical Devices	October 2, 2014	Final
Medical Device Accessories - Describing Accessories and Classification Pathways	December 20, 2017	Final
Software as a Medical Device (SAMD): Clinical Evaluation	December 8, 2017	Final
Deciding When to Submit a 510(k) for a Software Change to an Existing Device	October 25, 2017	Final
Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices	September 6, 2017	Final
Postmarket Management of Cybersecurity in Medical Devices	December 28, 2016	Final
Applying Human Factors and Usability Engineering to Medical Devices	February 3, 2016	Final
Radio Frequency Wireless Technology in Medical Devices	August 14, 2013	Final
Computer-Assisted Detection Devices Applied to Radiology Images and Radiology Device Data - Premarket Notification [510(k)] Submissions	July 3, 2012	Final
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	July 3, 2012	Final
Guidance: Acceptable Media for Electronic Product User Manuals	March 18, 2010	Final
Information for Healthcare Organizations about FDA's "Guidance for Industry: Cybersecurity for Networked Medical Devices Containing Off-The-Shelf (OTS) Software"	February 9, 2005	Final
Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices	May 11, 2005	Final

U.S. Food and Drug Administration

Guidances with Digital Health Content

List of FDA Guidance Documents with Digital Health Content

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List of FDA Guidance Documents with Digital Health Content

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