[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: 21CFR812.25]



[Page 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.  812.25  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.