[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2004]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR812.25]

[Page 103]
 
                        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. 812.25  Investigational plan.

    The investigational plan shall include, in the following order:
    (a) Purpose. The name and intended use of the device and the 
objectives and duration of the investigation.
    (b) Protocol. A written protocol describing the methodology to be 
used and an analysis of the protocol demonstrating that the 
investigation is scientifically sound.
    (c) Risk analysis. A description and analysis of all increased risks 
to which subjects will be exposed by the investigation; the manner in 
which these risks will be minimized; a justification for the 
investigation; and a description of the patient population, including 
the number, age, sex, and condition.
    (d) Description of device. A description of each important 
component, ingredient, property, and principle of operation of the 
device and of each anticipated change in the device during the course of 
the investigation.
    (e) Monitoring procedures. The sponsor's written procedures for 
monitoring the investigation and the name and address of any monitor.
    (f) Labeling. Copies of all labeling for the device.
    (g) Consent materials. Copies of all forms and informational 
materials to be provided to subjects to obtain informed consent.
    (h) IRB information. A list of the names, locations, and 
chairpersons of all IRB's that have been or will be asked to review the 
investigation, and a certification of any action taken by any of those 
IRB's with respect to the investigation.
    (i) Other institutions. The name and address of each institution at 
which a part of the investigation may be conducted that has not been 
identified in paragraph (h) of this section.
    (j) Additional records and reports. A description of records and 
reports that will be maintained on the investigation in addition to 
those prescribed in subpart G.