Why Regulatory and Reimbursement Strategies Must Align
Executive Summary
Synchronizing regulatory and reimbursement activities is the only way to avoid the "reimbursement gap"—the period where a device is FDA-cleared but lacks payer coverage. In 2026, market leaders align clinical trial endpoints to satisfy both FDA safety requirements and payer demands for comparative clinical effectiveness simultaneously.
Background
Synchronizing regulatory and reimbursement strategies for medical devices is essential for successful commercialization. Over the last 15 years, we guided more than 200 biomed companies in aligning FDA approval pathways with payer reimbursement requirements.
Too often, regulatory decisions are made without considering reimbursement objectives. This misalignment can delay coverage decisions—or, in some cases, prevent reimbursement entirely—despite successful regulatory approval.
Key Steps to Synchronize Regulatory and Reimbursement Plans
Frequently Asked Questions About the Intersection of FDA/Regulatory and Payer Requirements
Can I use the same clinical trial data for both FDA and Payers?
Often, no. FDA focuses on safety and efficacy, while payers require evidence of "comparative clinical effectiveness" and cost-utility. Synchronization ensures your trial design includes endpoints for both.
What is the FDA-CMS Parallel Review program?
It is a program that allows the FDA and CMS to review a medical device simultaneously to reduce the time between FDA marketing approval and national coverage (NCD).
Why is early reimbursement planning important for regulatory strategy?
It prevents "reimbursement gaps" where a product is legally cleared for sale but cannot be sold because no payment codes or coverage policies exist to support its adoption.
Medical Device Reimbursement Services by Country
About the Author
