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IDE Studies

Medicare regulations for FDA-approved Investigational Device Exemption (IDE) Studies

As a condition for participating in an IDE study, the principal investigator must furnish to National Government Services (NGS) information about the both the device and the study. These conditions and requirements are described in detail at Centers for Medicare and Medicaid Services (CMS) and NGS Investigational Device Exemption Requests.

The Certification Statement confirms that the principal investigator and her/his coordinator are aware of the additional requirements placed on them by Medicare if there is an intent to seek reimbursement for services in this study.
Download Certification Statement here.  Complete it, sign it, and send or hand-deliver it to:

Columbia University Medical Center
New York-Presbyterian Hospital
The Clinical Trials Office
622 West 168th Street
PH 15, Suite 1540
New York, NY 10032

For further information, please contact

Debra Fitzpatrick
Manager, Risk and Research Compliance
The Clinical Trials Office

Please continue to check the Clinical Trials Office website for additional and updated information about IDE studies.
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