FDA Payor Communications Guidance 2026: What Medical Device Manufacturers Need to Know

Medical Device Global Market Access · Jun 13, 2026 · 5m

The US FDA's June 3, 2026 draft guidance on manufacturer communications with payors marks a significant policy shift for the medical device industry. This episode breaks down how the guidance extends the safe harbor for sharing Healthcare Economic Information (HCEI) to medical devices and incorporates the Pre-Approval Information Exchange (PIE) Act. We discuss the practical implications for market access, what constitutes 'competent and reliable scientific evidence,' and the steps regulatory and commercial teams should take now to align with the FDA's new framework for communicating with…