Instructions for Completing the Exemption Request In accordance with University policies, the Cover Letter and attached materials should be submitted to the FDA through the Office for Investigator-Sponsored IND and IDE Support (O3IS) and include the O3IS address as the correspondence address for the Principal Investigator. Please see below: Name: Sponsor-Investigator Academic Department of Sponsor-Investigator University of Pittsburgh Hieber Building, Suite 303 3500 Fifth Avenue Pittsburgh, PA 15213 for Concurrence of “Request Exempt Status” A cover letter requesting the of your belief that the use FDA’s concurrence of said device in this clinical trial is exempt from the requirement to submit an IDE application. A copy of the Clinical Protocol Two paper copies of the submission (one for FDA, one for O3IS) Two CD e-Copies Any publications to support your case Formatting Requirements for IDE Submission . As of January 1, 2013, and as part of the MDUFA III agreements, IDE submissions to FDA are now required to include a valid electronic copy (eCopy) of the submission in a specific format. We have a link below to the new FDA guidance document on e-Copies for your reference. . Please read and note the following:
Instructions for Completing the Exemption Request In accordance with University policies, the Cover Letter and attached materials should be submitted to the FDA through the Office for Investigator-Sponsored IND and IDE Support (O3IS) and include the O3IS address as the correspondence address for the Principal Investigator. Please see below: Name: Sponsor-Investigator Academic Department of Sponsor-Investigator University of Pittsburgh Hieber Building, Suite 303 3500 Fifth Avenue Pittsburgh, PA 15213 “Request for Concurrence of Exempt Status” A cover letter requesting the FDA’s concurrence of your belief that the use of said device in this clinical trial is exempt from the requirement to submit an IDE application. A copy of the Clinical Protocol Two paper copies of the submission (one for FDA, one for O3IS) Two CD e-Copies Any publications to support your case Formatting Requirements for IDE Submission . As of January 1, 2013, and as part of the MDUFA III agreements, IDE submissions to FDA are now required to include a valid electronic copy (eCopy) of the submission in a specific format. We have a link below to the new FDA guidance document on e-Copies for your reference. . Please read and note the following:
IDE%20%20Exemption%20Request%20Template-.docx