Investigational Devices: Expanded Access

FDA regulations allow Expanded Access for the use of an unapproved medical device outside of the approved clinical trial parameters.  Expanded access for devices includes emergency use and treatment use ("Compassionate Use") of an investigational device to treat a patient(s) with a serious or immediately life-threatening disease or condition for which no satisfactory alternative therapy exists.

FDA regulations allow access to investigational devices for treatment purposes on a case-by-case basis for an individual patient, or for intermediate-size groups of patients with similar treatment needs who otherwise do not qualify to participate in the clinical trial.  The treatment must be for a serious disease or condition for which no alternative treatment is available to the patient.

For specific information on procedures at Emory see:

Emory IRB Guidance for IRB submission of Expanded Access - Devices

 

EMERGENCY USE - the FDA permits the use of an Investigational Medical Device in order to save a patient's life even though there is no current IDE for the device, or the patient does not meet the protocol criteria for the IDE, or the physician or institution is not an approved user/site under the IDE.  In this situation, Emory physicians should reference the steps outlined in IRB P & P 66 Emergency Use of Investigational Medical Devices (see link below).  Following use, the physician must promptly notify the Emory Institutional Review Board (IRB) and IDE Sponsor, or FDA if there is no IDE sponsor.

TREATMENT USE - the FDA permits an Investigational Medical Device to be used during a clinical study with patients who would appear to benefit from the device but do not meet the requirements for being included in the IDE clinical investigation.  In this situation, Emory physicians should reference the steps outlined in IRB P & P 67 Treatment Use of Investigational Devices (see link below).  A written Expanded Access IDE supplement must be submitted for review and approval by the FDA prior to use.  The treatment use must also be submitted for review and concurrence or approval of the IRB prior to beginning this treatment use of the investigational device for patients.

A licensed practitioner who holds the expanded access IDE and receives an investigational device for treatment use under an expanded access IDE is a "sponsor-investigator" and is responsible for meeting all applicable sponsor responsibilities as well as investigator responsibilities.  FDA reporting requirements include submission of progress reports.  Expanded Access regulations for devices are contained in Title 21, Code of Federal Regulations, Part 812.36.

For additional information see: