A few tips when crafting a (FDA CDRH) regulatory submission.
Use Q-subs, it's like free FDA consulting
Follow directions, get the basics right
Approach reviewers as allies, not adversaries
Tell the stories of the device and the patients it will help
Link the evidence to support the stories
Own up to uncertainty and unknowns
Discuss the risks in context
Make the reviewer's job as easy as possible
Be skeptical of yourself; assume you are biased and get third-party reviews
Lean into regulatory leadership's signals and public statements about the future
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