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									Emergency Use of an Investigational Device
Content Applies To
Office of Human Research Subjects Protection Institutional Review Board (IRB) Mayo
Clinic Rochester, Florida and Arizona

Purpose
This document describes the process for the emergency use of an investigational
device.

Scope
This procedure applies to clinicians who may request an emergency use of an
investigational device and to the Mayo Clinic Institutional Review Board (IRB) who
conducts the review and acknowledgement of emergency use requests submitted by
the clinician.

Background
An emergency use of an investigational device by a clinician without prior IRB review
and approval is permitted under 21 CFR 56.104(c). The one-time emergency use of an
investigational device is not consider research by the FDA but must be reported to the
IRB.

Key Terms
Emergency Use: The use of an investigational drug, agent, biologic, or device with a
patient in an immediate serious life-threatening situation in which no standard
acceptable treatment is available, and in which there is not sufficient time to obtain
approval by a fully convened IRB.
Investigational Device: Any healthcare product that does not achieve its primary
intended purposes by chemical action or by being metabolized. A medical device that is
the subject of a clinical study designed to evaluate the effectiveness and/or safety of the
device. Investigational use also includes clinical evaluation of certain modifications or
new intended uses of legally marketed devices.
Investigational Device Exemption: A FDA approved investigational device exemption
(IDE) permits a device that otherwise would be required to comply with a performance
standard or to have pre-market approval to be shipped lawfully for the purpose of
conducting investigations of that device.

Clinician Responsibilities
The clinician is responsible for:
      Contacting the manufacturer or sponsor to determine if the device can be made
       available for the emergency use under the company’s IDE.
      Obtaining Emergency Investigational Device Exemption Application (IDE) from
       the FDA if the manufacturer declines use of manufacturer's IDE.
      Notifying an IRB on-call Chair or Vice Chair to confirm that the proposed
       emergency use complies with the FDA regulations.
      Arranging for a physician not involved in the planned emergency intervention to
       assess and document in the medical record that the proposed emergency use is
       appropriate.
      Obtaining informed consent of the patient or the patient’s legally authorized
       representative.
      Reporting to the FDA and the IRB any adverse event or unanticipated problems
       with the emergency use of the investigational device.
      Completing the IRB Emergency Use Follow-up Form and submitting to the IRB
       electronically, via IRBe, within 5 working days of the emergency use of the
       investigational device.

IRB Responsibilities
The IRB is responsible for:
      Evaluating the clinician’s request for an emergency use of an investigational
       device and confirming that the emergency use request meets or does not meet
       the regulatory criteria for emergency use.
      Reviewing and acknowledging the Emergency Use Follow-Up submission and
       associated documentation at a convened IRB meeting.
      Notifying the clinician, via IRBe system, of the IRB’s review and
       acknowledgment.

Procedure for the Clinician
Obtaining an         The emergency use of an unapproved investigational device
Emergency IDE        requires an IDE. The clinician is responsible to obtain the
                     emergency use IDE by one of the following methods:
                         1. Contact the manufacture or sponsor of the investigational
                            device to determine if the investigational device can be
                            made available for the emergency use under the
                            manufacturer’s or sponsor’s IDE.
                         2. If the manufacture or sponsor does not have an active IDE
                            or if the manufacturer or sponsor will not permit the
                            emergency use of the IDE, then contact the appropriate
                            department at the FDA to obtain an emergency IDE.
                                 o For investigational devices, call 301-796-5640
                                 o After working hours (EST), call FDA’s Office of
                                   Emergency Operations, at 301-443-1240
                         3. Contact the Office of Research Regulatory Support (ORRS)
                            at 507-266-0022, (77)6-0022, or ORRS@mayo.edu for
                            assistance with the Emergency IDE submission to the FDA.
                     Note: An unapproved device may not be shipped in anticipation of
                     an emergency.
                     Note: Each of the following conditions must exist to justify
                     emergency use of an investigational device:
                             The patient is in a life-threatening condition that needs
                             immediate treatment (note: FDA considers life threatening
                             condition to include serious diseases or conditions such as
                             sight-threatening and limb-threatening conditions as well as
                             other situations involving risk of irreversible morbidity),
                            No generally acceptable alternative for treating the patient
                             is available, and
                            Because of the immediate need to use the device, there is
                             no time to use existing procedures to get FDA approval for
                             the use.
                     Note: The clinician must determine whether these criteria have
                     been met, to assess the potential for benefits from the unapproved
                     use of the device, and to have substantial reason to believe that
                     benefits will exist.
Notifying the on-    The clinician must notify the IRB on-call chairperson to inform
call IRB             him/her of the emergency use situation and if applicable, the need
chairperson          for a manufacturer release letter to be drafted.
                        1. To notify the on-call IRB chairperson, call the Mayo Clinic
                           (Rochester) Operator at 507-284-2511 or (77) 4-2511 and
                           ask for the IRB chairperson on-call.
                        2. As may be required by the manufacturer, request a letter of
                           IRB concurrent for the manufacturer to release the
                           investigational device.
Independent          Prior to the use of the investigational device, the clinician is
physician’s          responsible to obtain a written assessment from a physician not
assessment           involved in the emergency use with documentation that the
documentation        proposed emergency use is appropriate (i.e. the conditions for
                     emergency use are met), and if applicable, justification for not
                     obtaining informed consent from the patient or legally authorized
                     representative.
                     Note:
                     The physician’s independent assessment must be submitted to the
                     IRB via the IRBe (by accessing the Emergency Use Follow-up
                     Form) within 5 working days of the emergency use of the device.
Emergency Use        The clinician is responsible to obtain informed consent from the
Authorization Form   patient or the patient’s legally authorized representative prior to
                     the emergency use of the investigational device when possible.
                        1. Complete the Emergency Use Authorization Form,
                        2. Provide a copy to the patient or the patient’s legal
                           representative, and
                        3. Send a photocopy of the Emergency Use Authorization
                           document to the Mayo Clinic Health Information
                           Management Services (HIMS) scanning department for
                           scanning into the patient’s electronic medical record.
Emergency Use        The clinician is responsible to notify the IRB within 5 working days
Follow-up           of the emergency use of the investigational device by:
Submission to the      1. Logging into the IRBe system and completing the IRBe
IRB via the IRBe          Emergency Use Follow-up Form,
System
                       2. Attaching the independent physician’s assessment,
                       3. Attaching the Emergency Use Authorization document
                          provided to the patient or the patient’s legal representative,
                          and
                       4. Submitting the application and associated documentation
                          electronically to the IRB via the IRBe system.

Procedure for the IRB
Documentation of    When required by the manufacturer, IRB staff is responsible for
concurrence with    producing a written letter of IRB concurrence for the manufacturer
conditions for      to release of an investigational drug, agent, or biologic.
emergency use          1. Refer to template entitled: Letter to Manufacturer for
and follow-up             Release of an Investigational Drug, Agent, Biologic or
monitoring                Device for Emergency Use. An IRB senior specialist,
                          operations coordinator or manager, or administrator may
                          provide signature for the letter.
                       2. Scan and email the signed letter to the requesting clinician,
                          with a copy to the Mayo Clinic Office of Research
                          Regulatory Support (ORRS) at ORRS@mayo.edu. Include
                          reminder instructions to complete the IRBe Emergency Use
                          Follow-up Form via IRBe within 5 working days following
                          the emergency use.
                       3. Monitor and facilitate clinician completion of the IRBe
                          Emergency Use Follow-up Form, interacting with the
                          clinician as necessary.
                       4. Verify that an electronic copy of the IRB concurrence letter
                          is submitted in the clinician's IRBe Emergency Use Follow-
                          up Form or uploaded in an IRBe logged comment.
Evaluation of the      1. The emergency use follow-up application and associated
emergency use             documentation submitted by the investigator via the IRBe
request and IRB           system, is assigned to a convened IRB for review and
Committee                 acknowledgement.
acknowledgement        2. The convened IRB reviews and evaluates the clinician's
                          emergency use request of the investigational device. The
                          review consists of verifying the following:
                              o The sponsor's or manufacturer's authorization that
                                allows for the use of the investigational device,
                              o The approved IDE, or if applicable, a letter explaining
                                the IDE exemption from the FDA,
                              o A description of the situation regarding the
                                emergency use of the investigational device by the
                                     independent physician's assessment that certified
                                     the emergency use criteria,
                                 o The informed consent (i.e. Emergency Use
                                   Authorization) or, if applicable, the independent
                                   physician's assessment for the exception from
                                   obtaining informed consent.
                          3. The clinician is notified, via the IRBe system, of the IRB's
                             review.

Procedural Notes
Emergency use of the investigational device is limited to a single patient and data from
the single patient use may not be used as part of a prospective research study
conducted by the clinician or sponsor of the device without IRB approval
(communication from Mayo Legal 12/16/2009).
The Emergency Use Follow-up Form requests the following information from the
clinician:
      Name of the investigational test article (i.e. device)
      Name and date of the IRB chairperson consulted prior to the emergency use
      Data and time the investigational test article (i.e. device) was administered or
       used with the patient
      Conditions under which the investigational test article (i.e. device) was
       administered or used
      Copies of the independent physician's assessment and the Emergency Use
       Authorization (consent document)
      Protective measures taken prior to the emergency use
      Adverse events or unanticipated problems to the recipient or others
      Outcomes, if known
The expectation of the FDA in granting an Emergency IDE in the event that the
manufacturer does not agree to the use of the product is that the clinician, now the
sponsor of the IDE, promptly submits the appropriate documentation to the FDA to
support the IDE. IF the FDA does not receive the application within 30 days of the date
on the Emergency Investigational Device Exemption Application letter, the FDA will
deem the IDE to be canceled prior to use of the investigational product. Any use of the
product will not have been in compliance with the Federal Food, Drug, and Cosmetic
Act or with the licensing provisions of the Public Health Service Act.

Related Documents
Emergency Use Authorization Form IRB 10346
Letter to Manufacturer for Release of an Investigational Drug, Agent, Biologic or Device
for Emergency Use Form IRB 10048
Emergency Use of Investigational Drug, Agent, Biologic or Device Process IRB 10365
Emergency Use Follow-Up - IRBe System Application IRB 10265
References
21 CFR 812
FDA Information Guidance FAQs about IRB Review of Medical Devices

								
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