The following steps should be completed to obtain approval for Expanded Access requests:
Step 1: Contact the Manufacturer
- For all types of investigational medical products, the FDA requires that the clinician contact the manufacturer to see if they will provide the investigational medical product for expanded access use. Investigational medical products may be provided through a supplement to a manufacturer’s existing IND or IDE, or through an IND or IDE specific to the use (e.g., under a Treatment IND or Treatment IDE).
Step 2: Submit Request to the FDA
- For drugs and biologics, clinicians MUST contact the FDA prior to any use of the investigational product.
- Step-by-step instructions for drugs/biologics are here: https://www.fda.gov/news-events/expanded-access/expanded-access-how-submit-request-forms.
- For devices, clinicians MUST contact the FDA prior to any use that is NOT an emergency. Prior contact with the FDA for an emergency use of a device is not required IF certain criteria are met. See Emergency Use (Initial Notification to FDA).
- Step-by-step instructions for devices are here: https://www.fda.gov/medical-devices/investigational-device-exemption-ide/expanded-access-medical-devices#compassionate.
Step 3: Obtain IRB approval and informed consent from the patient(s)
- Once the appropriate expanded access route has been identified and the FDA and drug/biologic/device manufacturer contacted, treating teams will need to submit an application through ARROW for prospective IRB approval, using the Expanded Access Application type. Expanded access requests for the use of a drug for a single patient may be reviewed by the Chair or designee in lieu of convened board review if the study team has requested a waiver from the FDA by checking box 10(b) on FDA Form 3926. Expanded access requests for the use of a device in an individual patient may be reviewed by the Chair or designee in lieu of convened board review.
Study teams are encouraged to use the expanded access consent template for drugs and devices.