21 CFR § 812.25 - Investigational plan.
---
identifier: "/us/cfr/t21/s812.25"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 812.25 - Investigational plan."
title_number: 21
title_name: "Food and Drugs"
section_number: "812.25"
section_name: "Investigational plan."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "H"
subchapter_name: "MEDICAL DEVICES"
part_number: "812"
part_name: "INVESTIGATIONAL DEVICE EXEMPTIONS"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
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."
regulatory_source: "45 FR 3751, Jan. 18, 1980, unless otherwise noted."
cfr_part: "812"
---
# 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.