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Records Management Program <[log in to unmask]>
Subject:
FDA Definition
From:
"Kuitert, Chris" <[log in to unmask]>
Date:
Thu, 11 Nov 2004 10:28:09 -0600
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Records Management Program <[log in to unmask]>
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Is there a medical device manufacturing listserver out there that would be willing to share their interpretation of what the FDA term Life of Device means?

In a meeting yesterday a compliance consultant defined it as the requirement to retain all quality records from the time a device is first manufactured to the time the last product is introducted to the market. In our case we have manufactured a certain product for nearly 30 years.

I have interpreted it as the number of years the device is functional.

Chris Kuitert
RIM Specialist

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