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Are your RSA vials approved by the FDA for use in clinical/toxicology applications?

Reference Number: AA-02031 Created: 12/16/2013 10:32 AM Last Updated: 03/28/2017 05:01 PM

The FDA does not "approve or disapprove" of vials for use in analytical testing. Therefore any vial may be used for this purpose to be compliant with FDA regulations including the RSA™.

However, if the vials are used for human clinical testing or packaging of pharmaceuticals, the end user might need to validate and get FDA-certified. Please check with your regulatory department. The RSA vials are designed for analytical testing and while this application would be outside the scope of the products' intended use,  since RSA vials are not coated and are TYPEI borosilicate glass, they do not fall into a problem category such as with a coating and are simpler to get validated.

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