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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?
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?