2016 FDA Final Guidance for Blood Glucose Monitoring Systems - Implementation

missjenny

Involved In Discussions
#1
So, after issuing the draft versions in 2014, FDA has finalized the guidances for blood glucose monitoring systems just a couple of days ago.

My question is, will these be applicable to 510(k) submissions that are currently being reviewed officially or unofficially?

Are there any past comments from the FDA or precedents or experiences that you might have had regarding the finalization or introduction of a new guidance in the midst of a reviewing process?
 
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P

Pearce

#2
Jenny,

This isn't exactly what you asked about but it's related and I thought I'd share it.

I asked the FDA about whether a Special 510(k) submission based on previously cleared meters would be accepted and I received the following response:

Future BGMS or SMBG devices, or future modifications to currently cleared BGMS and SMBG devices, should be developed according to the recommendations in the finalized guidance documents.

Hope this helps somewhat.
 

missjenny

Involved In Discussions
#3
Thank you for sharing your communication with the FDA.

However, this seems strange to me as Appendix II of the final guidance clearly states that special 510(k) may continue to be submitted with only validation in regards to the parts being modified of own previously cleared meters as long as the meters share the same fundamental scientific technology.

Did the they mention anything in regards to this by any chance?
 
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