[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: 21CFR812.20]

[Page 108-109]
 
                        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.  812.20  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.

[[Page 109]]

    (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 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]