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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:
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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
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Debra Fitzpatrick
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Manager, Risk and Research Compliance
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The Clinical Trials Office
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342-1581
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df2111@columbia.edu
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Please continue to check the
Clinical Trials Office website
for additional and updated information about IDE studies.
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