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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 [email protected].

List of FDA Guidance Documents with Digital Health Content

Issue Date Guidance Guidance Status
09/28/2022 Clinical Decision Support Software Final
04/08/2022 Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions Draft
12/23/2021 Digital Health Technologies for Remote Data Acquisition in Clinical Investigations Draft
11/04/2021 Content of Premarket Submissions for Device Software Functions Draft
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
09/27/2019 Off-The-Shelf Software Use in Medical Devices Final
09/02/2014 Content of Premarket Submissions for Management of Cybersecurity in Medical 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
07/03/2012 Computer-Assisted Detection Devices Applied to Radiology Images and Radiology Device Data - Premarket Notification [510(k)] Submissions Final
07/03/2012 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
05/11/2005 Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices Final

 

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