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What should be included in your software description for your regulatory submission?

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About the Author
Proxima CRO Team
Isabella Schmitt, RAC
Director of Regulatory Affairs
Ms. Schmitt has also served in additional regulatory affairs and clinical research roles in which she contributed to multiple regulatory submissions and clinical affairs projects across a wide range of indications.

FDA recommends that you provide a comprehensive overview of the device features that are controlled by software, and describe the intended operational environment. Generally, it is recommended that you provide the information in paragraph format and highlight major or operationally significant software features. The software description should include information on the following:

  • programming language
  • hardware platform
  • operating system (if applicable)
  • use of Off-the-Shelf software (if applicable)

If your device uses Off-the Shelf software, please refer to the FDA guidance document “Guidance for Off-the-Shelf Software Use in Medical Devices.” If this information is included in another document, such as the Software Requirements Specification, your submission should contain an annotation and a reference to the document in the submission where this information is located.

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