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  1. Academic MOUs

MOU 225-25-014

MEMORANDUM OF UNDERSTANDING BETWEEN TRUSTEES OF DARTMOUTH COLLEGE ON BEHALF OF ITS GEISEL SCHOOL OF MEDICINE AND THE U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES FOOD AND DRUG ADMINISTRATION CENTER FOR DEVICES AND RADIOLOGICAL HEALTH

I. Purpose

The United States Food and Drug Administration (“FDA”) and Trustees of Dartmouth College, on behalf of its Geisel School of Medicine (“Dartmouth”) (FDA and Dartmouth together referred to as, “the Parties”) share interests in promoting scientific progress and translating innovation and discoveries into practice in the areas of health and medicine. Both institutions foresee benefits from furthering public policy efforts, translating innovation and discoveries into medical practice, and scientific training for academicians, clinicians, and students to foster a well-grounded foundation in interdisciplinary science on which scientific learning can grow.  

This Memorandum of Understanding (“MOU”) sets forth the framework under which the collaboration can take place.  Activities that may take place during the collaboration include collaborative research, public outreach, extension activities, and disciplinary and medical device development training.

II. Background

FDA is authorized to enforce the Federal Food, Drug, and Cosmetic Act (“the Act”) as amended (21 U.S.C. 301). In fulfilling its responsibilities under the Act, FDA, among other things, directs its activities toward promoting and protecting the public health by ensuring the safety, efficacy, and security of drugs, biological products, veterinary products, medical devices, and radiological products and the safety and security of foods and cosmetics. CDRH is responsible for assuring that patients and providers have timely and continued access to safe, effective, and high-quality medical devices and safe radiation-emitting products. To accomplish its mission, FDA takes efforts to stay abreast of the latest developments in research and communicate with stakeholders about complex scientific and public health issues.

Dartmouth is a private, coeducational research university located in Hanover, New Hampshire and founded in 1769. Geisel School of Medicine at Dartmouth was founded in 1797 and holds as its mission to address the world’s health problems through research and discovery, the evaluation and improvement of systems of healthcare, and the education of the best future physicians and scientists. Dartmouth has established the Dartmouth Device Development (3D) Scholars Program (“Program”) which aims to grow the field of clinicians capable of bridging clinical care, science, and public policy. The Program intends to equip physicians with an advanced understanding of the field to drive progress in medical device development.

FDA benefits from this partnership by having the Program participants (“Scholars”) educated in regulatory science best practices.  These Scholars may, at a later point in their career, participate in research, evaluation, dissemination, and interagency activities, with the potential to bring new perspectives and skills to FDA.

III. Goals of Collaboration

FDA and Dartmouth share a mutual interest in exposing researchers, healthcare providers, and scientists to a policy environment, thereby expanding and enriching the field’s capacity for translational research and medical devices. The Parties want Scholars to have a better understanding of the medical device development pathway, including relevant regulation and the authorization process.

The goals of the FDA/CDRH Dartmouth collaboration are:

  1. To contribute to the effective use of scientific and regulatory knowledge during the medical device development process; and
  2. To educate the scientific and clinical community about the role regulation plays in the medical device development process.

IV. Responsibilities of the Parties

This MOU forms the basis for the development of scientific and intellectual collaborations, outreach, and educational initiatives between FDA and Dartmouth, including during the Program. To the extent permitted by law, FDA will contribute public information on medical device regulation, as well as public information on how medical devices may be authorized. FDA will provide mentoring, depending on staffing resources and legal authority.

Prior to the initiation or implementation of any specific collaboration, the Parties intend to identify priorities and topics of mutual interest and enter into agreement(s), as necessary. The agreement(s) will outline each Party’s financial commitments (if any) to the collaboration and the specific terms to govern the collaboration.

The Parties will not, as a part of the activities covered by this MOU, share any non-public information, including  (1) confidential commercial information, such as the information that would be protected from public disclosure pursuant to Exemption 4 of the Freedom of Information Act (FOIA); (2) personal privacy information, such as the information that would be protected from public disclosure pursuant to Exemption 6 or 7(c) of the FOIA; or (3) information that is otherwise protected from public disclosure by Federal statutes and their implementing regulations (e.g., Trade Secrets Act (18 USC 1905)), the Privacy Act (5 USC 552a), other Freedom of Information Act exemptions not mentioned above (5USC 552(v)), the Federal Food, Drug, and Cosmetic Act (21 USC 301 et seq.), and the Health Insurance Portability and Accountability Act (HIPAA), Pub. L. 104-191).

V. Liaison Officers

For CDRH: 
Brittany Caldwell, Ph.D., M.B.A.       
Director, Division of Partnerships and Innovation
CDRH/OST/DPI
Tel: (301) 348-3954
E-mail: Britany.Caldwell@fda.hhs.gov

Christina Webber, Ph.D.
Partnership & Collaboration Program Manager
CDRH/OST/DPI
Tel: (301) 796-3351
Email: Christina.Webber@fda.hhs.gov

For Dartmouth:
Duane Compton, Ph.D.
Dean, Geisel School of Medicine 
The Dean’s Office
Geisel School of Medicine at Dartmouth
Tel: 603-646-5200
E-mail: Duane.A.Compton@dartmouth.edu

Each Party may designate new liaisons at any time by notifying the other Party's administrative liaison in writing. If at any time, an individual designated as a liaison under this agreement becomes unavailable to fulfill those functions, the Party affected will name a new liaison within two weeks and notify the other Party through the designated administrative liaison.

VI. Term, Termination, and Modification

This agreement becomes effective upon acceptance by both Parties and will continue in effect for five (5) years from the date of the latest signature.  It may be renewed by mutual written agreement of both Parties.  It may be modified at any time by mutual written agreement of both Parties.  It may be terminated by either Party upon 60-day advance written notice to the other.

VII. Statutes, Regulations, Rules, and Policies

This MOU and all associated agreements will be subject to the statutes, regulations, rules, and policies applicable to FDA and Dartmouth.

IN WITNESS WHEREOF, the Parties, by their undersigned representatives, have caused this MOU to be executed.  This MOU may be executed in counterparts and each counterpart shall be deemed an original.

APPROVED AND ACCEPTED FOR TRUSTEES OF DARTMOUTH COLLEGE

/s/
Duane Compton, Ph.D.
Dean, Geisel School of Medicine
Geisel School of Medicine at Dartmouth
Date: 09/09/2025

APPROVED AND ACCEPTED FOR THE U.S. FOOD AND DRUG ADMINISTRATION’S CENTER FOR DEVICES AND RADIOLOGICAL HEALTH

/s/
Michelle Tarver, M.D., Ph.D.
Center Director
Center for Devices and Radiological Health
Date: 09/12/2025

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