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What is the documentation required for a software-related submission?
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About the Author
Proxima CRO Team
Isabella Schmitt, RAC
Director of Regulatory Affairs

Prior to joining Proxima, Isabella served as the Senior Regulatory & Quality Manager at a medical device company, where she outlined the regulatory strategy & put together design controls & design history documentation. She was the Dir. of CMC & Quality at a biopharmaceutical company, where she oversaw all manufacturing and analytical processes and timelines and ensured CMC regulatory strategy was sufficient for filings in Europe and the US.

Software-related documentation that you provide in your premarket submission should be consistent with the intended use of the Software Device, the Level of Concern, and the type of submission. This section describes the documentation that the FDA recommends you include in your premarket submission based on the Level of Concern. However, you should follow the recommendations in device-specific guidance, if available for your device. In general, the documentation provided in your submission should:

  • describe the design of your device
  • document how your design was implemented
  • demonstrate how the device produced by your design implementation was tested
  • show that you identified hazards appropriately and managed risks effectively
  • provide traceability to link together design, implementation, testing, and risk management.

These recommendations are keyed to the Level of Concern of your device and are predicated on your effective implementation and management of the QSR, including Design Controls.

FDA believes the recommended documents will generally be the same documents that you would normally generate during the development of a Software Device. Therefore, in a properly managed and documented medical device software development environment, the documents that you submit in response to the recommendations in this guidance may be copies of your product development documents.

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