Regulatory Open Forum

FDA requires labels to be put on base label of the blood bag.  The adhesive of the labels should be in compliance with 21 CFR 21 according to this guideline: Uniform Labeling of Blood and Blood Components

For labels directly put on the blood bag, it has to go thru 510(k), correct? 

Thanks!


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Summer Young
USA
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should be in compliance with 21 CFR section 175.105

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Summer Young
USA
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Original Message:
Sent: 09-Sep-2019 15:46
From: Summer Young
Subject: adhesive compliance for labels on blood bag

FDA requires labels to be put on base label of the blood bag.  The adhesive of the labels should be in compliance with 21 CFR 21 according to this guideline: Uniform Labeling of Blood and Blood Components

For labels directly put on the blood bag, it has to go thru 510(k), correct?

Thanks!


------------------------------
Summer Young
USA
------------------------------