Software Contained In Medical Devices Guidance

Content of Premarket Submissions for Software …

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-content-premarket-submissions-software-contained-medical-devices

Center for Devices and Radiological Health This guidance document is intended to provide information to industry regarding the documentation that we recommend you include in premarket...

Guidance for the Content of Premarket Submissions …

https://www.fda.gov/files/medical%20devices/published/Guidance-for-the-Content-of-Premarket-Submissions-for-Software-Contained-in-Medical-Devices---Guidance-for-Industry-and-FDA-Staff.pdf

For the purposes of this document, we refer to devices that contain one or more software components, parts, or accessories, or are composed solely of software …

Software as a Medical Device (SaMD) | FDA

https://www.fda.gov/medical-devices/digital-health-center-excellence/software-medical-device-samd

Guidances with Digital Health Content | FDA

https://www.fda.gov/medical-devices/digital-health-center-excellence/guidances-digital-health-content

Content of Premarket Submissions for Device Software …

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/content-premarket-submissions-device-software-functions

2 See FDA website on " Software as a Medical Device (SaMD) ." 3 As a reminder, manufacturers of device software must create and maintain software-related …

Premarket Submissions - Cybersecurity in Medical …

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/content-premarket-submissions-management-cybersecurity-medical-devices

This guidance has been developed by the FDA to assist industry by identifying issues related to cybersecurity that manufacturers should consider in the design and …

FDA In Brief: FDA Provides New Draft Guidance on …

https://www.fda.gov/news-events/press-announcements/fda-brief-fda-provides-new-draft-guidance-premarket-submissions-device-software-functions

The proposed recommendations in this draft guidance document pertain to device software functions, including both software in a medical device (SiMD) and …

FDA Software Guidances and the IEC …

https://sunstonepilot.com/2018/09/fda-software-guidances-and-the-iec-62304-software-standard/

The basic message of this guidance is that medical device companies are responsible for all of the software in their products, including software libraries and other off-the …

General Principles of Software Validation | FDA

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/general-principles-software-validation

Center for Devices and Radiological Health Center for Biologics Evaluation and Research This guidance outlines general validation principles that the Food and Drug …

Medical devices: software applications (apps) - GOV.UK

https://www.gov.uk/government/publications/medical-devices-software-applications-apps

Medical devices: software applications (apps) Information on when software applications are considered to be a medical device and how they are …