SW (Software) Deferred Bug Fix - FDA Requirements

S

Silvertabb

#1
What is the impact fixing a SW bug listed as deferred in the following scenarios?

1) Before submission of 510K to FDA
2) While 510k review of SW is in progress by FDA
3) After receiving 510k clearance from FDA

Note: in all cases, regression testing and final verfication test will be done.
 
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Stijloor

Staff member
Super Moderator
#2
What is the impact fixing a SW bug listed as deferred in the following scenarios?

1) Before submission of 510K to FDA
2) While 510k review of SW is in progress by FDA
3) After receiving 510k clearance from FDA

Note: in all cases, regression testing and final verification test will be done.
Can someone help?

Thank you!!

Stijloor.
 

glork98

Involved In Discussions
#3
What is the impact fixing a SW bug listed as deferred in the following scenarios?

1) Before submission of 510K to FDA
2) While 510k review of SW is in progress by FDA
3) After receiving 510k clearance from FDA

Note: in all cases, regression testing and final verfication test will be done.
It's not the "fixing" but the "releasing" that matters. I think that's what you meant.

1) This is the way to go. Submit the product you'll sell.

2&3 are the same. You need to inform the FDA that you've changed the product that they originally approved. Commonly called "letter to file." Consult your regulatory person.

If it's a large-scale or important fix, get it done before the 510k. No point in incurring attention (wrath) that might derail the product later on. I'm sure you're under pressure to make a deadline. Make the case that you need to submit the product you're going to sell.
 

yodon

Staff member
Super Moderator
#4
I agree with glork on this but want to add just a bit.

If, indeed, you are deferring the fix until some time after launch and this is well-known and understood, I think it would be wise to document "known issues" in your release documentation and do a risk analysis to show that it's not going to adversely affect safety or efficacy. If it does affect efficacy, then maybe additional mitigations; e.g., some user training, is require to work around the issue.

Good question - hopefully there will be some more discussion.
 
S

Silvertabb

#5
Deferred issues in my opinion are issues that fully disclosed and evaluated and confirmed to have no adverse impact on performance and safety/effectiveness. These issues could be in the range of cosmetic or cause minor inconvenience to users.
 
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