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This guidance applies to the emergency use of an unapproved medical device. For the purpose of the guidance, an unapproved medical device is a device that is utilized for a purpose, condition, or use for which the device requires, but does not have, an approved application for premarket approval or an approved application for an IDE. An unapproved device may be used in human subjects only if it is approved for clinical testing under an IDE. An emergency need to use an unapproved device may occur when an IDE for the device does not exist, when a physician wants to use the device in a way not approved under the IDE, or when a physician or institution is not approved under the IDE.

In an orderly developmental process, the developer of a device (a physician, scientist, or manufacturer) anticipates the need to conduct clinical studies and uses the IDE to ensure that adequate preclinical testing has been done, that the appropriate subjects will be selected, that subjects participate only after providing informed consent, that the device will be used properly, that subjects will be monitored adequately after the device is used, and that complete scientific data will be collected promptly. These data form the basis for subsequent marketing approval of the device.

FDA recognizes that even during the earliest phases of device design, development, and testing, emergencies arise where an unapproved device offers the only alternative for saving the life of a dying patient, but an IDE has not yet been approved for the device or the use, or an IDE has been approved but the physician who wishes to use the device is not an investigator under the IDE. Using its enforcement discretion, FDA will not object if a physician chooses to use an unapproved device in such an emergency, provided that the physician later justifies to FDA that an emergency actually existed.

Each of the following conditions should exist for a situation to be considered an emergency:

• the patient is in a life­threatening condition that needs immediate treatment;
  
• 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.

FDA expects the physician to 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. FDA further expects the physician not to conclude that an "emergency" situation exists in advance of the time when treatment may be needed based solely on the expectation that IDE approval procedures may require more time than remains. Physicians should be aware that FDA expects them to exercise reasonable foresight with respect to potential emergencies and to make appropriate arrangements under the IDE procedures far enough in advance to avoid creating a situation in which such arrangements are impracticable.

In the event that a device is used in circumstances meeting the criteria listed above, FDA would expect the physician to follow as many patient protection procedures as possible. These include obtaining:

• an independent assessment by an uninvolved physician;
  
• informed consent from the patient or a legal representative;
  
• institutional clearance as specified by institutional policies;
  
• the IRB chairperson's concurrence; and
  
• authorization from the sponsor, if an approved IDE for the device exists.

FDA would not object if an unapproved device were shipped without FDA approval to a physician who claims to be faced with, and describes, the kind of emergency situation discussed above. The person shipping the device should notify FDA, by telephone at 301­594­1190, immediately after shipment is made. An unapproved device may not be shipped in anticipation of an emergency.

After an unapproved device is used in an emergency the physician should:

• notify the IRB and otherwise comply with provisions of the IRB regulation (Part 56) and the informed consent regulation (Part 50);
  

• evaluate the likelihood of a similar need for the device in the future. If it is likely, immediately initiate efforts to obtain IRB approval and an approved IDE for the device's subsequent use;
  

• if an IDE exists, notify the sponsor of the emergency use of the device. The sponsor must comply with the reporting requirements of the IDE regulations; and
  

• if an IDE does not exist, notify FDA of the emergency use of the device and provide FDA with a written summary of the conditions constituting the emergency, patient protection measures, and any scientific results.

Subsequent use of the device in an emergency situation may not occur unless the physician or another person obtains approval of an IDE for the device and its use. If an IDE application for subsequent use has been filed with FDA and FDA disapproves the IDE application, the device may not be used even if the circumstances constituting an emergency exist. Developers of devices that could be used in emergencies should anticipate the likelihood of emergency uses and should obtain an approved IDE. FDA will consider taking regulatory action if an unapproved device is used in inappropriate situations.

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