Outline Regulatory and Clinical Reimbursement
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?
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LSWI Health Economics Consultation |
| Outline ultimate reimbursement plan | If no code exists, how will you obtain one? |