An unapproved medical device is defined as a device that is used for a purpose or condition for which the device requires, but does not have, an approved application for premarket approval under section 515 of the Federal Food, Drug and Cosmetic Act (21 U.S.C. 360). An unapproved device may be used in human subjects only if it is approved for clinical testing under an approved application for an Investigational Device Exemption (IDE) under section 510(g) of the Act (21 U.S.C. 360(i)(g) and 21 CFR part 812). Medical devices that have not received marketing clearance under section 510(k) of the FD&C Act are also considered unapproved devices which require an IDE.
The Food and Drug Administration (FDA) recognizes that emergencies arise where an unapproved device may offer the only possible life-saving alternative, but an IDE for the device does not exist, or the proposed use is not approved under an existing IDE, or the physician or institution is not approved under the IDE. Using its enforcement discretion, FDA has not objected if a physician chooses to use an unapproved device in such an emergency, provided that the physician later justifies to FDA than an emergency actually existed.
Each of the following conditions must exist to justify emergency use of an unapproved medical device:
- the patient is in a life-threatening 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. The physician may not conclude that an “emergency” 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 is available. 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 to be used in circumstances meeting the criteria listed above, the device developer should notify the Center for Devices and Radiological Health (CDRH) Program Operation Staff by telephone (301-594-1190) immediately after shipment is made. [Note - an unapproved device may not be shipped in anticipation of an emergency.] Nights and weekends, contact the FDA Office of Emergency Operations (HFA 614) 301-443-1240.
FDA expects physicians to follow as many subject protection procedures as possible. These include:
- obtaining an independent assessment by an uninvolved physician
- obtaining informed consent from the patient or a legal representative
- notifying institutional officials as specified by institutional policies
- notifying the Institutional Review Board (IRB) and
- obtaining authorization from the IDE holder if an approved IDE for the device exists