Skip to main content
Find a Lawyer

Code of Federal Regulations Title 21. Food and Drugs § 21.812.43 Selecting investigators and monitors

Current as of January 02, 2025 | Updated by Findlaw Staff

(a) Selecting investigators. A sponsor shall select investigators qualified by training and experience to investigate the device.

(b) Control of device. A sponsor shall ship investigational devices only to qualified investigators participating in the investigation.

(c) Obtaining agreements. A sponsor shall obtain from each participating investigator a signed agreement that includes:

(1) The investigator's curriculum vitae.

(2) Where applicable, a statement of the investigator's relevant experience, including the dates, location, extent, and type of experience.

(3) If the investigator was involved in an investigation or other research that was terminated, an explanation of the circumstances that led to termination.

(4) A statement of the investigator's commitment to:

(i) Conduct the investigation in accordance with the agreement, the investigational plan, this part and other applicable FDA regulations, and conditions of approval imposed by the reviewing IRB or FDA;

(ii) Supervise all testing of the device involving human subjects;  and

(iii) Ensure that the requirements for obtaining informed consent are met.

(5) Sufficient accurate financial disclosure information to allow the sponsor to submit a complete and accurate certification or disclosure statement as required under part 54 of this chapter. The sponsor shall obtain a commitment from the clinical investigator to promptly update this information if any relevant changes occur during the course of the investigation and for 1 year following completion of the study. This information shall not be submitted in an investigational device exemption application, but shall be submitted in any marketing application involving the device.

(d) Selecting monitors. A sponsor shall select monitors qualified by training and experience to monitor the investigational study in accordance with this part and other applicable FDA regulations.

Previous Part of Code Next Part of Code
Back to Chapter List

Cite this article: FindLaw.com - Code of Federal Regulations Title 21. Food and Drugs § 21.812.43 Selecting investigators and monitors - last updated January 02, 2025 | https://codes.findlaw.com/cfr/title-21-food-and-drugs/cfr-sect-21-812-43/

FindLaw Codes may not reflect the most recent version of the law in your jurisdiction. Please verify the status of the code you are researching with the state legislature before relying on it for your legal needs.

Was this helpful?

Welcome to FindLaw's Cases & Codes

A free source of state and federal court opinions, state laws, and the United States Code. For more information about the legal concepts addressed by these cases and statutes, visit FindLaw’s Learn About the Law.

Go to Learn About the Law

Latest Blog Posts

For Legal Professionals

Learn About The Law

Get help with your legal needs

FindLaw’s Learn About the Law features thousands of informational articles to help you understand your options. And if you’re ready to hire an attorney, find one in your area who can help.

Go to Learn About the Law

Need to Find an Attorney?

Search our directory by legal issue

Enter information in one or both fields (Required)

Copied to clipboard