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?

  • Insurance reimbursement vs Medicare/Medicaid
LSWI Health Economics Consultation
Outline ultimate reimbursement plan If no code exists, how will you obtain one?