Agreed, it would not be fun at all. You would have to prepare a de novo submission [1]. [1] https://www.fda.gov/medical-devices/premarket-submissions-selecting

Agreed, it would not be fun at all. You would have to prepare a de novo submission [1]. [1] https://www.fda.gov/medical-devices/premarket-submissions-selecting-and-preparing-correct-submission/de-novo-classification-request https://www.fda.gov/medical-devices/premarket-submissions-se...