---
kind: "section"
citation: "21 C.F.R. § 812.25"
title: "21"
number: "812.25"
heading: "Investigational plan."
url: "https://uscodex.org/cfr/21/812.25"
---

# §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)](#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.

## Notes

### Authority

Authority: 21 U.S.C. 331, 351, 352, 353, 355, 360, 360c-360f, 360h-360j, 360hh-360pp, 360rr-360ss, 360bbb-8b, 371, 372, 374, 379e, 381, 382; 42 U.S.C. 216, 241, 262.

### Source

Source: 45 FR 3751, Jan. 18, 1980, unless otherwise noted.