FDA Submissions and Lifecycle Management

After an initial application is FDA approved (IDE) or has the FDA ok to proceed (IND) the applicant Sponsor is required to maintain a current application with the FDA.  This section outlines ongoing and the final submission requirements.  OCR Regulatory can assist you with templates, planners, and submission support. Please contact us at PSOM-IND-IDE@POBOX.upenn.edu

Electronic submission is the preferred method for FDA IND submissions and a FDA form 1571 is always required (Form FDA 1571 and instructions). Secure email communications with the FDA require use of PennMedicine email accounts. The types of submissions required after the IND Application is open are summarized below in the table and more information can be found on the FDA Investigator-Initiated IND Applications webpage. 


2 IDE Submissions to the FDA

The types of IDE submissions required after the IDE application is approved are summarized in the table below1 and more information can be located on the FDA website IDE Reports and IDE Modifications

There are three types of IDE maintenance submissions to the FDA: Amendments, Reports and Supplements. 


3 Abbreviated IDE

Although original abbreviated IDE (aIDE) applications are not submitted to the FDA there are some instances where FDA reporting is required.  The below table summarizes Abbreviated IDE reporting requirements to the IRB and FDA.

4 References

1. NIH Clinical Center Regulatory Toolbox.

2. FDA IDE Reports.

3. FDA Guidance for Industry: Changes or Modifications During the Conduct of a Clinical Investigation; Final Guidance for Industry and CDRH Staff, May 2001.

4. 21 CFR 812.150.