FDA PMK 510(k) - IEC 62304 Software Components Segregation

[F_Traverso]

Hello,

I am currently working on a 510(k) notification for a medical device that includes a software module.

Since I am declaring compliance with 62304:2006 can I make use of the "segregation rule" (62304 cl. B.4.3), that allows to assign a different (lower) safety class (level of concern for FDA) to a specific software component respect to that assigned to the device?

This question arises because after an extensive search in the FDA resources, I have not noticed a formal reference on the possibility to segregate the software components and assign to them a level of concern (possibly lower than the level of the device) depending on their specific contribution to hazards.

Many thanks!

 

[Marcelo]

The level of concern of the FDA is different from the safety classification of IEC 62304. The general idea is the same (the "risk" defines the depth of the documentation required), but the FDA level of concern is directly related to the regulation (although it's in a guidance document), and the IEC safety classification is on a voluntary standard and deals only with the specific requirements of that standard.

In a general way, the FDA guidance is "more important" than the standard because it's what the agency expects. And as you noted, there's no option for segregation in the FDA documents.

 

[F_Traverso]

Thank you very much for the clarification.

However, I have a further question: without considering the safety class assigned (eventually by segregation ) through the 62304, is it appropriate to apply the segregation concept to the FDA level of concern for each software component?

You said that there is no option in FDA about segregation, does it mean that cannot be applied to the software or just that there is not a formal specification about this subject?

 

[Marcelo]

There's no formal comment in any document that I know, and the guidance on level of concern does not mention any option of lowering the level of concern.

On the other hand, the recognition of 62304 is for the complete standard, so this mean that you can use the standard as is (including safety classification and segregation). However, as I mentioned initially, this is different from the level of concern.

My suggestion is that you do not try to lower the level of concern, but you can lower the safety classification. This way you can comply with both expectations.