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Add properties required by FDA certification #104

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AlexanderYukhanov opened this issue Oct 17, 2024 · 4 comments
Open

Add properties required by FDA certification #104

AlexanderYukhanov opened this issue Oct 17, 2024 · 4 comments
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enhancement New feature or request

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@AlexanderYukhanov
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FDA requires (https://www.fda.gov/media/119933/download) suppliers to provide two additional attributes:
"

  • The software level of support provided through monitoring and maintenance from the
    software component manufacturer (e.g., the software is actively maintained, no longer
    maintained, abandoned); and
  • The software component’s end-of-support date.
    "

It would be beneficial to create taxonomy containing 4 additional attributes to meet this requirement:
fda:lifecycle:suport_level
fda:lifecycle:suport_level_comment
fda:lifecycle:end_of_support
fda:lifecycle:end_of_support_comment

The comment attributes are required to provide the justification for the provided attributes or the conducted effort description if those attributes were not detected

@jkowalleck
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@AlexanderYukhanov
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No, it's required to provide the level of support and justification both for level of support and the end of support date. Probably, we can extend cdx:lifecycle instead of declaring new fda:lifecycle like

cdx:lifecycle:suportLevel
cdx:lifecycle:suportLevelComment or cdx:lifecycle:suportLevelJustification
cdx:lifecycle: endOfSupportComment or cdx:lifecycle: endOfSupportJustification
?

@stevespringett
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Is there a definition of support level?

See also: Common Lifecycle Enumeration.

@jkowalleck jkowalleck added the enhancement New feature or request label Oct 19, 2024
@AlexanderYukhanov
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No, there is no formal definition or additional guidance from the FDA on this. That's why including a justification field alongside the support level is beneficial. It allows vendors to apply their own criteria (for example, using the OSSF Scorecard's 'Maintained' score).

The Common Lifecycle Enumeration currently covers different use-cases and is not well-suited for describing the support levels of dependencies, especially OSS one.

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