[Code of Federal Regulations]

[Title 21, Volume 8]

[Revised as of April 1, 2006]

From the U.S. Government Printing Office via GPO Access

[CITE: 21CFR812.36]



[Page 107-109]

 

                        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;

    (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;



[[Page 108]]



    (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 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



[[Page 109]]



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]