The guidance documents listed here are FDA guidances with Digital Health content and are intended to help industry and FDA staff understand FDA's regulation of digital health products.
Please note that the 21st Century Cures Act (12/13/2016) clarified FDA's regulation of medical software. The new law amended the definition of "device" in the Food, Drug and Cosmetic Act to exclude certain software functions, including some of those in the guidance documents below.
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
Software as a Medical Device (SAMD): Clinical Evaluation - Guidance for Industry and Food and Drug Administration Staff (PDF - 1.2MB) -December 08, 2017
Clinical and Patient Decision Support Software - Draft Guidance for Industry and Food and Drug Administration Staff (PDF - 461KB) -December 08, 2017
Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act - Draft Guidance for Industry and Food and Drug Administration Staff (PDF - 547KB) -December 08, 2017
Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices - Guidance for Industry and Food and Drug Administration Staff (PDF - 650KB) -February 09, 2015
General Wellness: Policy for Low Risk Devices - Guidance for Industry and Food and Drug Administration Staff (PDF - 786KB) -July 29, 2016
Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices - Guidance for Industry and Food and Drug Administration Staff (PDF - 421KB) -September 06, 2017
Medical Device Accessories - Describing Accessories and Classification Pathways - Guidance for Industry and FDA Staff (PDF - 449KB) -December 20, 2017
Mobile Medical Applications - Guidance for Industry and Food and Drug Administration Staff (PDF - 1.3MB) -February 09, 2015
General Principles of Software Validation - Final Guidance for Industry and FDA Staff (PDF - 367KB) -January 11, 2002
Off-The-Shelf Software Use in Medical Devices - Guidance for Industry, FDA Reviewers, and Compliance (PDF - 1.4MB) -September 09, 1999
Applying Human Factors and Usability Engineering to Medical Devices - Guidance for Industry and Food and Drug Administration Staff (PDF - 918KB) -February 03, 2016
Content of Premarket Submissions for Management of Cybersecurity in Medical Devices - Guidance for Industry and Food and Drug Administration Staff (PDF - 324KB) -October 02, 2014
Information for Healthcare Organizations about FDA's "Guidance for Industry: Cybersecurity for Networked Medical Devices Containing Off-The-Shelf (OTS) Software" -February 09, 2005
Postmarket Management of Cybersecurity in Medical Devices - Guidance for Industry and Food and Drug Administration Staff (PDF - 1.2MB) -December 28, 2016
Guidance for Industry and FDA Staff: Acceptable Media for Electronic Product User Manuals -March 18, 2010
Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices - Guidance for Industry and FDA Staff (PDF - 165KB) -May 11, 2005
Guidance for the Submission Of Premarket Notifications for Medical Image Management Devices - Guidance for Industry -July 27, 2000
Deciding When to Submit a 510(k) for a Software Change to an Existing Device - Guidance for Industry and Food and Drug Administration Staff (PDF - 585KB) -October 25, 2017
Radio Frequency Wireless Technology in Medical Devices - Guidance for Industry and FDA Staff (PDF - 139KB) -August 14, 2013
Computer-Assisted Detection Devices Applied to Radiology Images and Radiology Device Data - Premarket Notification [510(k)] Submissions - Guidance for Industry and Food and Drug Administration Staff -July 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 - Guidance for Industry and FDA Staff -July 03, 2012