Join Essenvia at RAPS Convergence 2026 — Booth #918
· Charlotte, 15–17 September
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Topic
Change assessment
Deciding whether a change to a marketed device needs a new submission — assessing design, material and supplier changes across FDA, EU MDR and other markets.
Letter to file, or new 510(k)? Working through FDA's change guidance
FDA's Change assessment framework
When does a device change require a new submission?
A decision framework for multi-market portfolios
Change Assessment in Medical Devices: Understanding Regulatory Implications
Navigating regulatory implications when making changes to medical devices is critical to ensuring compliance and market readiness. The evolving landscape demands a keen understanding of regulatory processes, especially in the United States, where the FDA oversees market entry through rigorous evaluations.