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U.S. Department of Health and Human Services

About FDA

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I.                   Purpose
The United States Food and Drug Administration (FDA)'s Center for Devices and Radiological Health (CDRH) and the President and Fellows of Harvard College on behalf of Harvard Medical School (“Harvard”) have a shared interest in promoting regulatory science for postmarket surveillance and epidemiological study of medical devices. Both FDA and Harvard are referred to individually as a "Party" and collectively as the "Parties." This Memorandum of Understanding (MOU) establishes the terms for collaboration to promote these shared interests, which can be pursued through a variety of programs including collaborative research, public outreach, extension activities, cooperative international initiatives, and disciplinary 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, CDRH is responsible for protecting and promoting public health by assuring the safety and effectiveness of medical devices and the safety of radiation-emitting products. To accomplish its mission, FDA must stay abreast of the latest developments in research and communicate with stakeholders about complex scientific and public health issues. 
In 2010, FDA launched Medical Device Epidemiology Network (MDEpiNet) Initiative to develop national/international infrastructure and innovative methodological approaches for conducting robust studies and surveillance that, through Public-Private Partnership with academia and other stakeholders, will improve the understanding of medical device safety and effectiveness throughout the device life cycle. FDA has stated a strategy for enhancing medical device surveillance in a white paper entitled: “Strengthening Our National System for Medical Device Postmarket Surveillance”, published in September 2012 and updated in April 2013. This strategy depends on meaningful stakeholder engagement through the development of public-private partnerships dedicated to the mission of enhancing public health through the development of new epidemiological methods, and new data infrastructure capable of supporting detailed analysis of medical device use and associated outcomes.
The evolving Medical Device Epidemiology Network (MDEpiNet) Public-Private Partnership is envisioned to advance the national postmarket surveillance capabilities for medical devices through broad based stakeholder engagement. In forming the MDEpiNet Public-Private Partnership (PPP), the intent is to provide an open, public forum where all interested or affected parties can collaborate to advance public health. The specific objectives of the MDEpiNet are to:
1.                  Improve the paradigm of how medical device knowledge is generated, appraised, and utilized throughout the medical device life cycle
2.                  Leverage partner resources and expertise to create a sustainable, robust infrastructure through which stakeholders will continue to gain valuable knowledge about medical devices
3.                  Become fully integrated in the systematic postmarket evaluation of medical devices.
Harvard Medical School is an institution of higher education whose mission is to create and nurture a diverse community of the best people committed to leadership in alleviating human suffering caused by disease.
FDA and Harvard share interests in developing regulatory science for medical devices and in enhancing the understanding of the safety, effectiveness, quality, and performance of medical devices.
III.             Substance of the Agreement
This MOU forms the basis for development of scientific and intellectual collaborations, outreach and educational initiatives between FDA and Harvard in support of the implementation of MDEpiNet. All activities undertaken pursuant to the MOU are subject to the availability of personnel, resources, and funds and the execution of separate Supplemental Agreements (as defined below) governing such activities. The types of activities expected to develop from this partnership include, but are not necessarily limited to the following:
·         Identification and convening of committees to support the mission and activities of MDEpiNet that include membership from thought leaders in the patient, academic, industry, hospital, payer, and medical professional sectors;
·         Joint workshops and meetings for education and research;
·         Research collaborations in regulatory science; and
·         Sharing of unique facilities, equipment, and infrastructure for enhanced results and cost efficiencies for scientific endeavors.
MDEpiNet projects are divided into separate “work streams”, defined by a common theme. The “Methodology Work Stream” consists of projects related to developing novel epidemiological methods to analyze data related to medical device patient exposure and clinical outcomes coming from multiple primary data sources. 
Under this MOU, Harvard will establish the coordinating center for the Methodology Work Stream. As the coordinating center, Harvard will manage specific projects and maintain relationships with other MDEpiNet coordinating centers and governance committees. Supplemental Agreements (as defined below) between FDA, Harvard, and/or other partners may be required to further support these activities. Harvard, as the coordinating center for the MDEpiNet PPP Methodology Work Stream, agrees to work openly with other parties who have an interest in or are affected by the work of MDEpiNet and to provide administrative, logistical, and scientific support and guidance as agreed to by the parties
Before any specific collaboration is initiated or implemented, the Parties shall identify priorities, topics of mutual interest, and, as needed, develop separate, written agreements ("Supplemental Agreements") for each collaboration that will outline each Party's financial commitments (if any) to the collaboration and the terms to govern the collaboration. Where applicable, these Supplemental Agreements shall incorporate by reference the terms of this MOU. The Supplemental Agreements may include contracts, grants or cooperative research and development agreements ("CRADAs") between FDA and Harvard to the extent authorized by law and available appropriations. Supplemental Agreements may also be executed with other partners to support projects through the MDEpiNet Work Stream. The terms and conditions of any Supplemental Agreements will be in accordance with applicable federal law and regulations, and shall be negotiated and executed by appropriate representatives of Harvard, FDA, and/or other partners.
IV.             General Provisions
·        Data Sharing Guidelines: The Parties may enter into separate Confidential Disclosure Agreements (CDAs) pertaining to certain data and information shared pursuant to this MOU. In accordance with applicable disclosure statutes and FDA regulations, FDA will not share any confidential commercial information, trade secrets, or personal privacy information with Harvard, unless waiver is obtained from the owner of such information. See 21 U.S.C. 331(j), 21 U.S.C. 360j(c), 18 U.S.C. 1905, 21 CFR 20.61 and 20.63.
·        Intellectual Property:  “Invention” refers to any subject matter or discovery patentable under Title 35 of the United States Code and conceived or first reduced to practice under the activities of Supplemental Agreements to the MOU.  “Intellectual Property” refers to patents, patent applications, know-how, trade secrets, copyrights and computer programs either used or developed under the activities of Supplemental Agreements to the MOU.  Ownership of and rights to Inventions or Intellectual Property developed under a Supplemental Agreement will be addressed in the Supplemental Agreement.  Inventions made under a Federal research and development grant or contract will be subject to the Bayh-Dole Act.  No Party, by virtue of their participation in activities under the MOU, will be required to disclose or license intellectual property to the other Party. Neither Party shall use the name, logos, trademarks, service marks, trade names, seals, insignia, symbols or decorative designs of the other Party or any derivatives thereof without the prior written permission of the other Party. The Parties may, however, reference the existence of this MOU. In any such statement, the relationship of the Parties shall be accurately and appropriately described.
·        Conflict of Interest: Individual participants in activities under this MOU who are not U.S. Government employees will be expected to abide by conflict of interest rules and policies as specified by FDA, and as set out in any Supplemental Agreement covering those activities. This may require individual participants to disclose their financial holdings and those of their spouse and minor children, and may limit their ability to accept gifts and have employment with entities that are substantially regulated by FDA. The Parties will be advised of any potential conflict so that conflicting assignments can be avoided consistent with the HHS/FDA requirements. If at any time prior to or during the performance of the activities under the MOU, the Parties believe that a potential or actual conflict exists, the Parties must notify the appropriate authorities within their respective institutions and contact the designated FDA officials listed on the MOU so that the necessary action/s can be undertaken. A determination will be made by FDA as to whether a conflict of interest exists and, if so, as to how to resolve or mitigate it. The Parties to the MOU will make every effort to avoid activities or relationships that would cause a reasonable person to question the impartiality of their actions.
·        Security: Each Party will inform the other Party of its security policies and procedures regarding access to and use of facilities, and the other Party will comply with those policies.  Either Party may restrict or limit access to its property and facilities, at any time, for any reason.  Harvard individuals participating in activities under this MOU on FDA’s property will comply with all applicable federal statutes and regulations. Employees or agents of the FDA participating in activities under this MOU on Harvard’s property will comply with all Harvard policies.
V.                Resource Obligations
This MOU represents the broad outline of the FDA and Harvard’s intent to collaborate in areas of mutual interest. It does not create binding, enforceable obligations against any Party. All activities that may be undertaken by this MOU are subject to the availability of personnel, resources, and funds. This MOU does not affect or supersede any existing or future agreements or arrangements among the Parties and does not affect the ability of the Parties to enter other agreements or arrangements related to this MOU.
VI.             Liaison Officiers
Danica Marinac-Dabic, M.D., Ph.D.
Director, Division of Epidemiology
10903 New Hampshire Avenue
White Oak Building 66, Room 4110
Silver Spring, MD 20993
Administrative Contact for Harvard Medical School:
Melissa Korf
Grants and Contracts Officer
25 Shattuck Street, Suite 509
Boston, MA 02115
Technical Contact for Harvard Medical School:
Sharon-Lise Normand, Ph.D.
Department of Health Care Policy
Harvard Medical School
180 Longwood Avenue
Boston, MA 02115-5899
Phone: 617-432-3260
E-mail: sharon@hcp.med.harvard.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 Parties will name a new liaison within two weeks and notify the other Party through the designated administrative liaison.
VII.          Term, Termination, and Modification
This agreement becomes effective upon execution by both Parties and will continue in effect for five (5) years. 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.
VIII.       Statutes, Regulations, Rules, and Policies
This MOU and all associated agreements will be subject to the applicable statutes, regulations, rules, and policies under which FDA and Harvard operate.
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.



Jeffrey S. Flier, M.D.                                          Jeffrey Shuren, M.D., J.D.
Dean of the Faculty of Medicine                     Director
Harvard Medical School                                  Center for Devices and Radiological Health

April 8, 2014                                                        April 8, 2014