Software Validation - Splitting the Level of Concern on multiple software parts

[SaschaK]

Hello,
I have a probleme and need your assistance for clarification.

In the Guidance for the Content of Premarket Submissions for Software Contrained in Medical Device the FDA writes always about the Level of Concern for a software device (which i understand is the complete software)

In the 62304 the Classification for the Software can be done also be seperated for Components, Elements.

E.g I have a active component which I want to define as class A / minor level of concern and i have an independent safety component which completly controlls all hazards (Class C, major concern).
I can prove the independency of the two.

My question is can I split the Level of Concern on multiple software parts ?
Is there some more concret information from the FDA for this issue ?
If yes, what do i have to pay attention to ?


Thanks Sascha

I am new to this forum and i really hope to have some interesting discussions ...

[Marcelo Antunes]

Hello Sascha and welcome to the cove!

The guidance document does not permit decompositions of the level of concern, as IEC 62304 does to classification.

Although IEC 62304 is a recognized consensus standard for the FDA (http://www.accessdata.fda.gov/scrIpt...l.cfm?id=22436), it only seems to fulfill the Software Development Environment Description of the guidance..thus, the level of concern would not be included.

So, my opinion is that you cannot do this splitting for the FDA.

Let´s see if others have more info about this.

[SaschaK]

Thanks.

After the post and some more thinking I came to the same conclusion.
Although the definitions are the same for software class and level of concern, I should NOT mix them up.

Software Class adresses the Software Process depth
Level of Concern adresses documents which come out of the software process.

I was misslead by an "expert presentation"