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Status:Closed    Asked:May 14, 2014 - 12:01 PM

Are the ISTA-2A and ISTA-3A procedures recognised by the FDA?

FDA approval requires adherence to a certain quality of work. ASTM is recognised as a packaging testing method for FDA approval, however I am not sure if ISTA is also recognised as such.

 
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ISTA tests or derivatives are being used and accepted by the FDA. In the medical device industry, an accepted umbrella standard is ISO 11607. 11607 references the ISTA 1, 2, and 3 Series, tests from these Series are being used by many companies, and are being accepted by the FDA. ISTA 2A is quite popular, with ISTA 3A also being adopted by many organizations.

 

May 14, 2014 - 12:01 PM

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