Title 21

SECTION 812.25

812.25 Investigational plan.

§ 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.