[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: 21CFR812.20]



[Page 103-104]

 

                        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.  812.20  Application.





    (a) Submission. (1) A sponsor shall submit an application to FDA if 

the sponsor intends to use a significant risk device in an 

investigation, intends to conduct an investigation that involves an 

exception from informed consent under Sec.  50.24 of this chapter, or if 

FDA notifies the sponsor that an application is required for an 

investigation.

    (2) A sponsor shall not begin an investigation for which FDA's 

approval of an application is required until FDA has approved the 

application.

    (3) A sponsor shall submit three copies of a signed ``Application 

for an Investigational Device Exemption'' (IDE application), together 

with accompanying materials, by registered mail or by hand to the 

address in Sec.  812.19. Subsequent correspondence concerning an 

application or a supplemental application shall be submitted by 

registered mail or by hand.

    (4)(i) A sponsor shall submit a separate IDE for any clinical 

investigation involving an exception from informed consent under Sec.  

50.24 of this chapter. Such a clinical investigation is not permitted to 

proceed without the prior written authorization of FDA. FDA shall 

provide a written determination 30 days after FDA receives the IDE or 

earlier.

    (ii) If the investigation involves an exception from informed 

consent under Sec.  50.24 of this chapter, the sponsor shall prominently 

identify on the cover sheet that the investigation is subject to the 

requirements in Sec.  50.24 of this chapter.

    (b) Contents. An IDE application shall include, in the following 

order:

    (1) The name and address of the sponsor.

    (2) A complete report of prior investigations of the device and an 

accurate summary of those sections of the investigational plan described 

in Sec.  812.25(a) through (e) or, in lieu of the summary, the complete 

plan. The sponsor shall submit to FDA a complete investigational plan 

and a complete report of prior investigations of the device if no IRB 

has reviewed them, if FDA has found an IRB's review inadequate, or if 

FDA requests them.

    (3) A description of the methods, facilities, and controls used for 

the manufacture, processing, packing, storage, and, where appropriate, 

installation of the device, in sufficient detail so that a person 

generally familiar with good manufacturing practices can make a 

knowledgeable judgment about the quality control used in the manufacture 

of the device.

    (4) An example of the agreements to be entered into by all 

investigators to comply with investigator obligations under this part, 

and a list of the names and addresses of all investigators who have 

signed the agreement.

    (5) A certification that all investigators who will participate in 

the investigation have signed the agreement, that the list of 

investigators includes all the investigators participating in the 

investigation, and that no investigators will be added to the 

investigation until they have signed the agreement.

    (6) A list of the name, address, and chairperson of each IRB that 

has been or will be asked to review the investigation and a 

certification of the action concerning the investigation taken by each 

such IRB.

    (7) The name and address of any institution at which a part of the 

investigation may be conducted that has not been identified in 

accordance with paragraph (b)(6) of this section.

    (8) If the device is to be sold, the amount to be charged and an 

explanation of why sale does not constitute commercialization of the 

device.

    (9) A claim for categorical exclusion under Sec.  25.30 or 25.34 or 

an environmental assessment under Sec.  25.40.

    (10) Copies of all labeling for the device.

    (11) Copies of all forms and informational materials to be provided 

to subjects to obtain informed consent.

    (12) Any other relevant information FDA requests for review of the 

application.

    (c) Additional information. FDA may request additional information 

concerning an investigation or revision in the investigational plan. The 

sponsor



[[Page 104]]



may treat such a request as a disapproval of the application for 

purposes of requesting a hearing under part 16.

    (d) Information previously submitted. Information previously 

submitted to the Center for Devices and Radiological Health in 

accordance with this chapter ordinarily need not be resubmitted, but may 

be incorporated by reference.



[45 FR 3751, Jan. 18, 1980, as amended at 46 FR 8956, Jan. 27, 1981; 50 

FR 16669, Apr. 26, 1985; 53 FR 11252, Apr. 6, 1988; 61 FR 51530, Oct. 2, 

1996; 62 FR 40600, July 29, 1997; 64 FR 10942, Mar. 8, 1999]