Applying to use an investigational drug or device outside of a clinical trial on a case-by-case basis can be difficult. The FDA has provided a streamlined process to aid investigators and ensure subjects receive the care they need.

While a traditional IND or IDE application can be used, FDA Form 3926 may be an easier approach for investigators.

Although a clinical investigation is not taking place under an Expanded Access IND or IDE, investigators are still responsible for all federal regulations that apply to INDs/IDEs. Major responsibilities are listed below. Please consult a regulatory expert and 21 CFR 312 or 812 for a complete listing.

• Ensure IRB and FDA approval prior to treatment
• Obtain appropriate informed consent
• Maintain accurate and complete treatment and regulatory documentation
• Report SAEs to IRB and FDA
• Submit annual reports as necessary to FDA
• Formally close out IND/IDE with the FDA when treatment is complete

If you have any questions regarding Expanded Access Submissions, please contact the Clinical Research Compliance Office at This email address is being protected from spambots. You need JavaScript enabled to view it..

Helpful Links:

• FDA Form 3926
• FDA guidance for Form 3926
• Expanded Access Information for Physicians