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  • Writer's pictureShannon Lantzy

How to get a submission through FDA

A few tips when crafting a (FDA CDRH) regulatory submission.

  1. Use Q-subs, it's like free FDA consulting

  2. Follow directions, get the basics right

  3. Approach reviewers as allies, not adversaries

  4. Tell the stories of the device and the patients it will help

  5. Link the evidence to support the stories

  6. Own up to uncertainty and unknowns

  7. Discuss the risks in context

  8. Make the reviewer's job as easy as possible

  9. Be skeptical of yourself; assume you are biased and get third-party reviews

  10. Lean into regulatory leadership's signals and public statements about the future

  11. Assume nothing about the review team's disposition and prior knowledge

The reality is that there is both art and science in judging technology. Reviewers have a tough job. Make it as easy on them as possible by crafting your story and your evidence in concert with each other.

~Shannon, the Optimistic Optimizer

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