IEC 62304 was brought up during an FDA Inspection/Audit

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yodon

Staff member
Super Moderator
#3
Can't let a good discussion topic go unanswered...

Really short answer: no.

Add on: I have heard anecdotally (maybe somewhere in this forum?) that the FDA inspector didn't accept it (no elaboration given).

62304 is a recognized consensus standard by the FDA which made me wonder about the story above.

The one thing I've noticed is that 62304 doesn't require any requirements verification for Class A software. This has always puzzled me. This is clearly inconsistent with FDA documentation requirements for a minor level of concern.
 
R

robertjbeck

#4
I just took a quick run through the standard, and basically you're correct. The only sections that involve verification and that apply to Class A are:

5.1.6 Software verification planning
8.2.3 Verify changes
9.7 Verify software problem resolution

I don't think it's puzzling that FDA's requirements don't mesh exactly with this ISO standard, since the classification categories are slightly different, the two sets of requirements were developed mostly independently, and FDA has a different approach than the EU, MDD, and ISO.
 

c.mitch

Quite Involved in Discussions
#5
Hi
I didn't want to give my two cents, 'cause I've never had such experience.
But, now that other contributors have answered, I give my two cents!
The main difference btw Fda and IEC 62304 is the difference of criteria to establish software classification.
-Sw security class in 62304
-Sw level of concern (loc) in fda guidances.
Plus the discrepancy of sw verification btw class A and low loc.
Given these two differences applying 62304 is not enough, even if it's a good framework. Manufacturers shall "strengthen" the application of 62304 by applying additional requirements found in fda guidances.
 
#6
For those wondering why there is little verification requirement in 62304 (particularly for Class A) can I highlight figure 2 given in annex C - Software as part of the V-model.

This shows the elements of the overall design and development of software and the verification and validation activities that are outside the scope of 62304.
 
R

robertjbeck

#7
this has turned into an interesting discussion. my original intent was to discover if anyone has had actual experience where FDA has brought up 62304 in either an inspection or during the review of a premarket submission.
 
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