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Monday, May 15, 2017 10:23:52 AM
Like almost everything associated with the design and manufacture of medical devices the FDA also provides guidelines for packaging and labeling requirements.. The ISO standard for medical device labeling requirements is ISO 15223-1, not, "what your thought" is. They absolutely can reference the FDA on their packaging if they so desire, they are quite simply, incompetent.
If they don't have it on the package then it is not allowed. You can verbally say it or you can put it in a paragraph but you can't include it on a package as it may sound like an endorsement.
That is my thought.
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