Category Archives: Pre-Submission Meeting

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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Pre-submission Meeting Request Feedback Options

fdaecopy/ January 20, 2017/ Pre-Submission Meeting/ 1 comments

Article analyzes feedback methods offered by the FDA for a pre-submission meeting request and gives you insight to which option is best for your situation. In 2014 the FDA published a guidance document about pre-submission meeting requests (i.e., pre-sub meetings). The purpose of a pre-submission meeting is to ask and obtain answers to your questions directly from the FDA. The

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