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  1. FDA Memoranda of Understanding

MOU 225-18-029

Memorandum of Understanding
Between
The U.S. Food and Drug Administration
Center for Devices and Radiological Health and
The University of Kentucky

I. Purpose

The United States Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDR H) and the University of Kentucky (UK) (the Parties) have a shared interest in scientific progress in the diverse disciplines that directly and indirectly affect human and animal health and medicine.  The Patties have an interest in better understanding the bioengineering performance of many regulated medical and surgical devices.
The parties want to collaborate on biomedical engineering projects of importance to the regulatory science priorities at CDRH. The parties aim to promote an integrative approach based on coupled experimental and computational investigations routinely used at UK for advancing regulatory science, improving regulatory approval pathways, and facilitating better regulatory awareness, acceptance and utilization.

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 assuring the safety, efficacy, and security of drugs, veterinary products, medical devices and radiological products and the safety and security of foods and cosmetics (Appendix A). To accomplish its mission, FDA must stay abreast of the latest developments in research and also communicate with stakeholders about complex scientific and public health issues.
The Bioengineering Lab at UK is well-respected and has expertise of specific relevance to many aspects of the CDRH Regulatory Science mission as detailed on their website. Prof Zhang is an AIMBE Fellow and has published widely on areas as diverse as biomaterials and computational modelling. UK research experience includes, but is not limited to, the following areas: Orthopedic Biomechanics & Biomaterials, Implant Retrieval, Carbon/PEEK Composites, Testing and Evaluation of Biomaterials, Testing Methods & Devices, Cell/Biomaterial Interactions, Micro/Nanotechnology-Based Biosensors, Nano-pore Devices & Biosensors, Engineering for Biological Interfacing, Fabrication of Micro/Nano Substrates, and Computational Bioengineering.

III. Substance of the Agreement

This MOU forms the basis for development of scientific collaborations between FDA and UK.  The types of activities expected to develop from this MOU include:

Planning of a collaborative regulatory research program related to both the CDRH mission and UK's research interests.
Exchange non-confidential data and confer on analyses.
Collaboration on manuscripts for publication, ensuring that all research results and data are made available to the public.

FDA will:

Share data from results of research at CDRH with UK.
Provide expertise on regulatory science.
Make OSEL laboratories available to guest researchers -students, faculty and post-docs from UK, as appropriate and pursuant to FDA regulations and guidelines.

UK will:

Provide access to research experience in the following areas: Orthopedic Biomechanics & Biomaterials, Implant Retrieval, Carbon/PEEK Composites, Testing and Evaluation of Biomaterials, Testing Methods & Devices, Cell/Biomaterial Interactions, Micro/Nanotechnology-Based   Biosensors, Nano­ pore Devices & Biosensors, Engineering for Biological Interfacing, Fabrication of Micro/Nano Substrates, and Computational Bioengineering.
Share research on biomaterials and devices based on in vitro models, simulated in vivo models, preclinical models, retrieval studies and user behavior.
Offer access to engineering technologies in the form of fluidics and bioreactors, biosensors, and high-resolution imaging.
Develop multidisciplinary and multiscale computational models to mimic the situation in biological investigation.
Additionally, it is agreed that:

1. Rights to any inventions resulting from collaborative research will be determined by the separate written research agreements governing the effort, based on current U.S. Government patent regulations and any other applicable statutes and regulations.
2.  UK and CDRH may decide to enter into Cooperative Research and Development Agreements (CRADA) specific to particular collaborative projects. The terms of such CRADAs will address intellectual property rights.
3. Proprietary and/or nonpublic information will not be disclosed under this MOU, unless such disclosure is governed by appropriate confidentiality disclosure agreements, and to the extent such disclosure is permitted by law.
4. This agreement may be amended any time upon mutual agreement between the parties in writing.

IV. Contacts

FDA's Center for Devices and Radiological Health (CDRH) is the lead Center at RDA
for this MOU. The individuals to whom all inquiries to FDA should be addressed to are:

Edward Margerrison, Ph.D. Director
FDA/CDRH/OSEL
10903 New Hampshire Avenue WO 62, Rm 3214
Silver Spring, MD 20993
Phone: (301) 796-0262
Email: Edward.Margerrison@fda.hhs.gov

The individual to whom all inquiries to UK University should be addressed is:

Guigen Zhang, Ph.D.
Department Chair, College of Engineering F Joseph Halcomb III, MD Endowed Chair University of Kentucky
522A Robotics and Manufacturing Building 143 Graham Avenue
Lexington, KY 40506-0108
Phone: (859) 323-7217
Email: guigen.bme@uky.edu

V. Period of Agreement

This agreement becomes effective upon acceptance by both parties and will continue in effect for five (5) years and may be renewed upon mutual agreement of the parties.

VI. Regulations

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

VII. Signature of Responsible Parties

U.S. Food and Drug Administration, Center for Devices and Radiological Health
Jeffrey Shuren, M.D., JD.
Director
/s/
September 18, 2018

University of Kentucky
Kim C. Carter
Executive Director OSPA
/s/
September 18, 2018