Hi,

The CDRH Guidance Document entitled “Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices” (dated May 11, 2005), requires the submitter of a 510(k) to submit a list of unresolved bugs.

Assuming that all the bugs have been assessed as minor with no affect on safety or performance, are there any guidelines as to the amount of bugs that may be submitted? In other words, do we also need to assess if the total quantity of individual bugs (all minor) may affect the overall quality and performance of the medical device??

Or, to phrase the question differently, is there a point at which quantity affects quality, and therefore the FDA will ask us to fix all the bugs before clearing the 510(k) submitted for a Class IIa medical device?

Thanks a lot.

Asherlee

As I'm sure you've read, the software section guidance says:

For Moderate and Major Level of Concern Software Devices, the submission should include a list of all unresolved software anomalies. For each anomaly, we recommend that you indicate the:


problem
impact on device performance
any plans or timeframes for correcting the problem (where appropriate).

It does not seem to specifically request what you're asking, but you could do it as part of the impact on device performance, ie, how does this bug relate to other known bugs. I also doubt the FDA would complain if you included additional analysis on the summary effects of known bugs. Really, it is hard to say how they will react to a long list of minor items- are they actually bugs and not typos or something like that? I would try to get it down before submission!

Can you please, give some examples of these unresolved anomalies, my software designers seem not ready to help me write this part! :mad:


As I'm sure you've read, the software section guidance says:
For Moderate and Major Level of Concern Software Devices, the submission should include a list of all unresolved software anomalies. For each anomaly, we recommend that you indicate the:


problem
impact on device performance
any plans or timeframes for correcting the problem (where appropriate).

It does not seem to specifically request what you're asking, but you could do it as part of the impact on device performance, ie, how does this bug relate to other known bugs. I also doubt the FDA would complain if you included additional analysis on the summary effects of known bugs. Really, it is hard to say how they will react to a long list of minor items- are they actually bugs and not typos or something like that? I would try to get it down before submission!

Can you please, give some examples of these unresolved anomalies, my software designers seem not ready to help me write this part! :mad:

Scotman,

I am not an FDA rules and regulations expert.

But I decided to "google" on: "Moderate and Major Level of Concern Software Devices (http://www.google.com/search?hl=en&q=Moderate+and+Major+Level+of+Concern+Software+Devices&btnG=Google+Search)."

Anything that you can use there?

There are a few FDA experts here at The Cove Forums. However, it is Friday, the weekend is coming up...so patience may be the key here...

Good luck with your challenge. :agree1:

Stijloor.