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.
|Things to Consider
|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?