Practical questions answered at the workshop:
- How do you obtain a 510(k) in today's environment at FDA? How do you position your 510(k) submission? How do you fashion the intended use statement and argue the technological characteristics are the same and do not raise "new types" of questions of safety and effectiveness?
- What to do when things do not go right? How do you answer Additional Information (AI) letters, when and how to push back meetings with FDA, whom to include and how to prepare the appellate process at CDRH, what avenues to pursue and when?
- When you get your 510(k), how do you market a product with a general intended use statement when your product can be used in many specific indications/
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