If you are conducting a study with an investigational agent, the Centers for Medicare & Medicaid Services (CMS) have specific guidance on Investigational Device Exemptions (IDEs).
Approval for Investigational Device Exemptions (IDEs)
This page details Medicare coverage related to investigational device exemption (IDE) studies.
If you have questions about any of the resources on this page, please contact the sponsoring office directly. MICHR is not responsible for the content of these resources.
Resources on this page may not be an exhaustive list. If you know of other resources in this category, please let us know using the "Suggest a Resource" link at the bottom of the page.