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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
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
Multiple Function Device Products: Policy and Considerations April 27, 2018 Draft
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

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