Catch up 510(k) - Non-significant changes were made

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#1
Hi all,

I have a question regarding an old 510(k). Since the device was cleared, a number of non-significant changes were made. At the time it was thought that these changes (and cumulative changes) were not significant.

However, we are now thinking it would be safest to submit a catch-up 510(k) similar to that discussed in the article below.

https://www.nsf.org/newsroom_pdf/md_raps_rf_catch_up_510K.pdf

My concern is that by submitting a 510(k) to the FDA we are also stating that a significant change has occurred. Additionally, it doesn't make sense for the FDA to be reviewing a 510(k) application for a device which has been on the market for a number of years...

Has anybody else submitted a catch-up 510(k) in this manner?

:thanx:
 
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Mark Meer

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#2
Re: Catch up 510(k)

At the time it was thought that these changes (and cumulative changes) were not significant.
So, what do you think now? That the cumulative changes are indeed significant.

I presume you are familiar with the following FDA guidance:
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080235.htm

If you were to do a comparison between the cleared device and the current version using the flowcharts, do you come up with something that may be deemed significantly different?

I have not submitted at "catch-up" 510(k) (actually, first I've heard of this idea), but unless you are certain the changes are significant, I'd advise against it. For two reasons:
1. the overhead involved
2. depending on how long it's been since the original clearance, many of the FDA's priorities have shifted. You may find that they will be scrutinizing certain things more than in the past...

Ultimately it boils down to risk-management and documentation. At every stage of change, if you've documented and justified (through risk-assessment) that the changes are not significant, I think you're probably fine...
 
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