Description
Software Bill of Material (SBOM template) became an essential documents in the framework of regulatory submission of stand-alone software and for embedded software devices. The SBOM template can be basically considered a detailed list of all components and software dependencies involved in the development and delivery of a software application.
The SBOM in general includes both device manufacturer-developed components and third-party components, including purchased / licensed software and open-source software. For this reason, the Software Bill of Material Template can also be used for the documentation of the SOUP (Software of Unknown Provenance).
The template that shall be used for SBOM documentation is defined according to the document “Framing Software Component Transparency: Establishing a Common Software Bill of Materials (SBOM).”, which is suggested by FDA as a reference for SBOM documentation.
In the framework of FDA submission, like 510k and DeNovo, the Software Bill of Material is formally requested to be provide, especially for cyber devices, according to the definition mentioned in section 524B(b)(3) of the FD&C Act.
Among the elements that shall be addressed in a SBOM template, it is included:
- SW Component Name and Assets where the SW component resides
- SW Component Version
- Dependency relationship
- Component hash
- and much more.
Here at 4EasyReg we provide a SBOM template fully aligned with FDA and EU MDR requirements, including the requirements from NTIA. This template can be used for the preparation of regulatory submissions for SW-related medical devices. .
