Start with the product’s intended use and the evidence you have—not an assumed submission pathway. Use the following questions to structure a discussion with a qualified regulatory professional.
Define the product and its claims
Who will use it, what decision does it support, and which claims do you intend to make?
Identify the evidence gaps
What testing and validation do you already have? What safety, performance, and documentation questions remain?
Surface differing perspectives
Illustrative regulatory perspective: clarify intended use before discussing pathways. Illustrative product perspective: map evidence gaps while the product requirements are still evolving. The order may depend on how settled your design is.
Agree the next step
Prepare a one-page intended-use summary, an evidence inventory, and your unresolved questions for a qualified regulatory adviser.
Created as an example of the format only. No regulatory, legal, or medical advice is implied here.