FDA Guidances Regarding Medical Devices

Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (2005)

Draft Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act (2017)

General Principles of Software Validation (2002)

Medical Device Accessories – Describing Accessories and Classification Pathways (2017)

Mobile Medical Applications (2015)

General Wellness: Policy for Low Risk Devices (2016)

Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices (2015)

Draft Clinical and Patient Decision Support Software (2017)

Software as a Medical Device (SAMD): Clinical Evaluation (2017)

Draft Multiple Function Device Products:  Policy and Considerations (2018)

Content of Premarket Submission for Management of Cybersecurity in Medical Device (2014)

Cybersecurity for Networked Medical Devices Containing Off-The Shelf (OTS) Software (2005)

Postmarket Management of Cybersecurity in Medical Devices (2016)

Design Considerations and Premarket Submission Recommendation for Interoperable Medical Devices (2017)

Radio Frequency Wireless Technology in Medical Devices (2013)