Expanded Access to Devices

Overview

All Expanded Access pathways (except emergency use) require prospective FDA and IRB approval prior to use of an investigational product. Expanded Access treatment with an investigational device includes the following FDA submissions:

• Emergency Use
  • for emergency treatment of one patient
  • see Emergency Use guidance
• Compassionate Use
  • for treatment of one patient or small group
• Treatment IDE
  • for widespread use

See FDA Guidance on Expanded Access for Medical Devices for more information, including criteria and submission requirements.

Submitting to the Stanford IRB

Expanded Access protocols for non-emergency treatment with a medical device should be submitted to the IRB via eProtocol. The submission should include FDA documentation of the IDE authorization. Additional Sponsor Investigator Research training may be required if the Stanford Investigator is the sponsor of the IDE. For information on this training requirement, contact Spectrum at regulatory-spectrum@lists.stanford.edu.

Consent

Informed consent for expanded access treatment should be obtained in accordance with FDA regulations under 21 CFR 50.20. Use the Regular Consent with HIPAA template, revising the consent form to reflect the expanded access treatment program and removing references to "research".

Other Considerations

 Note that other Ancillary & Institutional Reviews may be required in addition to IRB approval.

FDA Guidance and Contact Info

• Expanded Access - Information for Physicians
• Expanded Access for Medical Devices
• FDA's Expanded Access Contact Information

See Other Types of Expanded Access

Page updated October, 2025