Hello Rene,
I don't think you'll find such a guidance. I had this discussion with FDA years ago, asking whether we could use refurbished parts in devices sold as new. All they could tell me was that as long as the finished devices met their performance specifications and cGMP is followed (proper qualification of the parts, etc.) they had no further interest. They referred me to the FTC, but their comments were even more vague.
I think if the device you are retrieving parts from is a new, OBF, you can certainly use the parts with a clear conscience.
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Patrick Lynch
Fremont CA
United States
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Original Message:
Sent: 03-26-2015 12:11
From: Rene' Hardee
Subject: Using piece parts from Out-of-box failed equipment?
Hello!
Can anyone point me to a requirement or guidance document that discusses dis-assembly of an out-of-box failed device for use as parts in new or repaired device? FDA, Canada, EU, anything!
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Rene' Hardee
Quality Specialist
Sun Nuclear Corporation
Melbourne FL
United States
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