Why is this Important? You have to understand what regulatory approvals you will need and how that will impact payment from payers, providers, and patients.
|Key Actions||Things to Consider||Tool Kit|
|Find professional regulatory consultant||Find a consultant with domain expertise (e.g. orthopedics) if possible|
|Outline initial labeling and indications for use for the MVP||Use minimum labeling – try for a 510k
Expanded indications may require expensive and/or lengthy clinical trials to prove efficacy or equivalence
|Outline regulatory requirements and action plan||Is your device likely to be considered a 510k, de novo 510k or PMA?
Seek multiple opinions on regulatory hurtles and strategy
Consider holding an FDA pre-sub meeting to clarify pathway
|Regulatory Questions Worksheet|
|Outline clinical trials required and timing||What evidence will be needed for EU CE Mark, FDA clearance/approval and/or reimbursement?|
|Outline existing reimbursement for similar products||What codes are used to reimburse similar products?
||LSWI Health Economics Consultation|
|Outline ultimate reimbursement plan||If no code exists, how will you obtain one?|