[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR812.36]

[Page 112-114]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 812_INVESTIGATIONAL DEVICE EXEMPTIONS--Table of Contents
 
             Subpart B_Application and Administrative Action
 
Sec.  812.36  Treatment use of an investigational device.

    (a) General. A device that is not approved for marketing may be 
under clinical investigation for a serious or immediately life-
threatening disease or condition in patients for whom no comparable or 
satisfactory alternative device or other therapy is available. During 
the clinical trial or prior to final action on the marketing 
application, it may be appropriate to use the device in the treatment of 
patients not in the trial under the provisions of a treatment 
investigational device exemption (IDE). The purpose of this section is 
to facilitate the availability of promising new devices to desperately 
ill patients as early in the device development process as possible, 
before general marketing begins, and to obtain additional data on the 
device's safety and effectiveness. In the case of a serious disease, a 
device ordinarily may be made available for treatment use under this 
section after all clinical trials have been completed. In the case of an 
immediately life-threatening disease, a device may be made available for 
treatment use under this section prior to the completion of all clinical 
trials. For the purpose of this section, an ``immediately life-
threatening'' disease means a stage of a disease in which there is a 
reasonable likelihood that death will occur within a matter of months or 
in which premature death is likely without early treatment. For purposes 
of this section, ``treatment use''of a device includes the use of a 
device for diagnostic purposes.
    (b) Criteria. FDA shall consider the use of an investigational 
device under a treatment IDE if:
    (1) The device is intended to treat or diagnose a serious or 
immediately life-threatening disease or condition;
    (2) There is no comparable or satisfactory alternative device or 
other therapy available to treat or diagnose that stage of the disease 
or condition in the intended patient population;
    (3) The device is under investigation in a controlled clinical trial 
for the same use under an approved IDE, or such clinical trials have 
been completed; and
    (4) The sponsor of the investigation is actively pursuing marketing 
approval/clearance of the investigational device with due diligence.
    (c) Applications for treatment use. (1) A treatment IDE application 
shall include, in the following order:
    (i) The name, address, and telephone number of the sponsor of the 
treatment IDE;

[[Page 113]]

    (ii) The intended use of the device, the criteria for patient 
selection, and a written protocol describing the treatment use;
    (iii) An explanation of the rationale for use of the device, 
including, as appropriate, either a list of the available regimens that 
ordinarily should be tried before using the investigational device or an 
explanation of why the use of the investigational device is preferable 
to the use of available marketed treatments;
    (iv) A description of clinical procedures, laboratory tests, or 
other measures that will be used to evaluate the effects of the device 
and to minimize risk;
    (v) Written procedures for monitoring the treatment use and the name 
and address of the monitor;
    (vi) Instructions for use for the device and all other labeling as 
required under Sec.  812.5(a) and (b);
    (vii) Information that is relevant to the safety and effectiveness 
of the device for the intended treatment use. Information from other 
IDE's may be incorporated by reference to support the treatment use;
    (viii) A statement of the sponsor's commitment to meet all 
applicable responsibilities under this part and part 56 of this chapter 
and to ensure compliance of all participating investigators with the 
informed consent requirements of part 50 of this chapter;
    (ix) An example of the agreement to be signed by all investigators 
participating in the treatment IDE and certification that no 
investigator will be added to the treatment IDE before the agreement is 
signed; and
    (x) If the device is to be sold, the price to be charged and a 
statement indicating that the price is based on manufacturing and 
handling costs only.
    (2) A licensed practitioner who receives an investigational device 
for treatment use under a treatment IDE is an ``investigator'' under the 
IDE and is responsible for meeting all applicable investigator 
responsibilities under this part and parts 50 and 56 of this chapter.
    (d) FDA action on treatment IDE applications--(1) Approval of 
treatment IDE's. Treatment use may begin 30 days after FDA receives the 
treatment IDE submission at the address specified in Sec.  812.19, 
unless FDA notifies the sponsor in writing earlier than the 30 days that 
the treatment use may or may not begin. FDA may approve the treatment 
use as proposed or approve it with modifications.
    (2) Disapproval or withdrawal of approval of treatment IDE's. FDA 
may disapprove or withdraw approval of a treatment IDE if:
    (i) The criteria specified in Sec.  812.36(b) are not met or the 
treatment IDE does not contain the information required in Sec.  
812.36(c);
    (ii) FDA determines that any of the grounds for disapproval or 
withdrawal of approval listed in Sec.  812.30(b)(1) through (b)(5) 
apply;
    (iii) The device is intended for a serious disease or condition and 
there is insufficient evidence of safety and effectiveness to support 
such use;
    (iv) The device is intended for an immediately life-threatening 
disease or condition and the available scientific evidence, taken as a 
whole, fails to provide a reasonable basis for concluding that the 
device:
    (A) May be effective for its intended use in its intended 
population; or
    (B) Would not expose the patients to whom the device is to be 
administered to an unreasonable and significant additional risk of 
illness or injury;
    (v) There is reasonable evidence that the treatment use is impeding 
enrollment in, or otherwise interfering with the conduct or completion 
of, a controlled investigation of the same or another investigational 
device;
    (vi) The device has received marketing approval/clearance or a 
comparable device or therapy becomes available to treat or diagnose the 
same indication in the same patient population for which the 
investigational device is being used;
    (vii) The sponsor of the controlled clinical trial is not pursuing 
marketing approval/clearance with due diligence;
    (viii) Approval of the IDE for the controlled clinical investigation 
of the device has been withdrawn; or
    (ix) The clinical investigator(s) named in the treatment IDE are not 
qualified by reason of their scientific training and/or experience to 
use the

[[Page 114]]

investigational device for the intended treatment use.
    (3) Notice of disapproval or withdrawal. If FDA disapproves or 
proposes to withdraw approval of a treatment IDE, FDA will follow the 
procedures set forth in Sec.  812.30(c).
    (e) Safeguards. Treatment use of an investigational device is 
conditioned upon the sponsor and investigators complying with the 
safeguards of the IDE process and the regulations governing informed 
consent (part 50 of this chapter) and institutional review boards (part 
56 of this chapter).
    (f) Reporting requirements. The sponsor of a treatment IDE shall 
submit progress reports on a semi-annual basis to all reviewing IRB's 
and FDA until the filing of a marketing application. These reports shall 
be based on the period of time since initial approval of the treatment 
IDE and shall include the number of patients treated with the device 
under the treatment IDE, the names of the investigators participating in 
the treatment IDE, and a brief description of the sponsor's efforts to 
pursue marketing approval/clearance of the device. Upon filing of a 
marketing application, progress reports shall be submitted annually in 
accordance with Sec.  812.150(b)(5). The sponsor of a treatment IDE is 
responsible for submitting all other reports required under Sec.  
812.150.

[62 FR 48947, Sept. 18, 1997]