Devices

8667804-the-medical-device-for-blood-pressure-and-pulse-measurement

 The use of investigational (IDE) devices at OHSU requires IRB approval and the use of an IRB-approved consent. Other internal approvals may be required as well. IDE studies require Medicare or Medicare Administrative Contractor (Noridian) approval.

 

IMPORTANT: Any clinical research study involving the use of a medical device or equipment at OHSU requires completion of the Clinical Research Device/Equipment Form

 

Investigational device Medicare preapproval

If a device study was assigned IDE status by the FDA after 1/1/2015:

  • The study sponsor is responsible for obtaining Medicare approval for ALL sites.
  • After Medicare approval is confirmed, OHSU is required to submit a Notification of Participation in IDE Device Study to Noridian informing them of our study participation.
    • PI/Study team will complete the form and submit to CoverAnalysis@ohsu.edu
    • Coverage Analysis will notify the PI/study team when acknowledgement is received from Noridian.
    • Subjects should NOT be enrolled at OHSU until acknowledgement has been received from Noridian.

 

If a device study was assigned IDE status by the FDA before 1/1/2015:

  • OHSU is responsible for obtaining Medicare approval for our site.
  • A Pre-Approval Data Submission Request must be sent to Noridian requesting approval of the study.
    • PI/Study team will complete the form and submit to , along with the required documents.
    • Coverage Analysis will notify the PI/study team when approval is received from Noridian.
    • Subjects should NOT be enrolled at OHSU until approval has been received from Noridian.

 

Investigational Device Exemption

 

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