Monthly Archives: March 2017

NSE letter: A CAPA plan for your 510k process

fdaecopy/ March 28, 2017/ NSE Letter, Pre-Submission Meeting/ 0 comments

Cry, complain, call the reviewer…you might feel a little better, but you received an NSE letter and tomorrow you still can’t sell your device. Instead, try approaching an NSE letter like a CAPA investigation. What is the issue? The FDA determined that your device is not substantially equivalent to the predicate you selected. What is the root cause? There are

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