Software Safety Classification

BCQuality76

Starting to get Involved
Does the new FDA Guidance eliminate the use of Level of Concern from General Principles of Software Validation (even though the new guidance still points to this one as a reference)?
 

Tidge

Trusted Information Resource
Does the new FDA Guidance eliminate the use of Level of Concern from General Principles of Software Validation (even though the new guidance still points to this one as a reference)?

The LoC is still sort-of there, it's just that what used to be 'moderate' or 'major' LoC have been effectively combined into the 'enhanced' category.

There was (in my experience) very little practical difference between the necessary deliverables for moderate and major LoC software systems. The list of deliverables for the moderate LoC was slightly shorter, but in order to generate those moderate deliverables most software projects would still have had to generate the deliverables for a LoC major system.... or generate a whole bunch of deliverables explaining how moderate was satisfied without the elements required by major... my experience had been that this was just leading to confusion in project planning, directing work effort, and crafting/reviewing submissions.

I have no insight into the change to basic/enhanced (beyond what is in the new guidance), but this division makes a lot more sense to me and it ought to focus both developers and reviewers on the necessary activities.
 

BCQuality76

Starting to get Involved
The LoC is still sort-of there, it's just that what used to be 'moderate' or 'major' LoC have been effectively combined into the 'enhanced' category.

There was (in my experience) very little practical difference between the necessary deliverables for moderate and major LoC software systems. The list of deliverables for the moderate LoC was slightly shorter, but in order to generate those moderate deliverables most software projects would still have had to generate the deliverables for a LoC major system.... or generate a whole bunch of deliverables explaining how moderate was satisfied without the elements required by major... my experience had been that this was just leading to confusion in project planning, directing work effort, and crafting/reviewing submissions.

I have no insight into the change to basic/enhanced (beyond what is in the new guidance), but this division makes a lot more sense to me and it ought to focus both developers and reviewers on the necessary activities.
Thank you for the quick response!
 
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