Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (2005)
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)
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)
Radio Frequency Wireless Technology in Medical Devices (2013)