Maintain the IDE: Supplements, Safety Reports, and Progress Reports

IDE sponsor-investigators are required under 21 CFR 812.50 to submit the following reports to the FDA as supplements to an approved IDE:

• Unanticipated adverse device effects;
• Withdrawal of IRB approval;
• Changes to the protocol;
• Changes made to the medical device;
• Device recalls;
• Progress report (as dictated by the FDA, but at least annually);
• Final report.

In addition, the FDA believes that expanding the study by increasing either the number of investigational sites or the number of study subjects participating in a clinical investigation affects the rights, safety, and welfare of the subjects. Therefore, the study may not be expanded without submission and approval of an IDE supplement.

The IDE supplement should be identified with the IDE number on the cover sheet and submitted via the eCopy process described in “file the IDE”.  The cover letter should identify the contents as “Supplemental IDE.”

For IDE supplements that require FDA approval, the FDA decision process is similar to that described for original IDE submissions, with the same decision options and review and response timelines. Similar to the original IDE application, an IDE supplement will receive a single decision for the entire supplement, i.e., approval, approval with conditions, or disapproval. A notable difference between FDA’s review of such supplements and the review of an original IDE submission is that FDA disapproval of the supplement does not imply that the IDE study itself is disapproved. For example, if a supplement to an approved IDE requests approval for changes to the clinical investigation and that supplement is disapproved, the sponsor may not implement the requested changes. However, the original IDE clinical investigation remains approved and may continue. For IDE supplements that are notifications or reports, FDA will respond to the sponsor within 30 days if FDA has questions or requests for additional information.

An unanticipated device effect (UADE) is any serious adverse effect on health or safety, any life-threatening problem or death caused by, or associated with a device, if that effect, problem, or death was not previously identified in nature, severity, or degree of incidence in the application; or any other unanticipated serious problem associated with a device that relates to the rights, safety, or welfare of subjects.

A UADE Report consists of a completed Form FDA 3500A and a cover letter that provides an analysis of the event, submitted to FDA and all reviewing IRBs and investigators within 10 working days after the sponsor-investigator first receives notice of the adverse effect.  Please note:  If you have difficulty opening this form in Google Chrome, try opening in another browser (i.e., Internet Explorer).

Progress reports must be submitted to FDA and all reviewing IRBs at the frequency dictated for the specific IDE by the FDA (at least annually).  A suggested format for the progress report can be found on the RDA CDRH website.