Memorandum of Understanding:
Streamlining Emerging Technology Medical Device Development Through Regulatory Tools
Food and Drug Administration, U.S. Department of Health and Human Services
Veterans Health Administration’s VA Ventures within the U.S. Department of Veterans Affairs
This Memorandum of Understanding (MOU) between the Food and Drug Administration (FDA) of the U.S. Department of Health and Human Services and the Veterans Health Administration (VHA), VA Ventures (VA Ventures) of the U.S. Department of Veterans Affairs (VA) (each a Party and collectively the Parties) provides a framework for collaboration intended to facilitate regulatory and basic science innovation surrounding the medical device development pathway with respect to emerging technologies. Special emphasis will be placed on interoperability. The Parties anticipate that this collaboration will yield metrics, training, protocols, and programs for medical products that utilize emerging technologies, including medical products that are manufactured close to the patient at the “Point of Care.” Emerging technologies may include, but are not limited to, 5G, immersive technologies, machine learning and artificial intelligence, additive manufacturing, and wearable technologies. The Parties intend to jointly develop a portfolio of regulatory science tools, training, and research outcomes that ensure Veterans and the American Public have access to the most innovative medical solutions and technologies to support their care. Specific projects and activities within the scope of this MOU will be addressed in separate implementing written agreements, as applicable.
II. AUTHORITIES & GOVERNING OFFICES
Department of Veterans Affairs (VA), Veterans Health Administration VA Ventures
(VA Ventures) is entering into this agreement under the authority of 38 U.S.C. § 7303. FDA has authority to enter into this agreement pursuant to 21 USC §393(b) and (c)of the Federal Food, Drug, and Cosmetic Act.
FDA is authorized to enforce the Federal Food, Drug, and Cosmetic Act (the Act) as amended (21 U.S.C. 301, et seq.). 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 human and veterinary drugs, biological products, and medical devices and by ensuring the safety of foods, cosmetics, and products that emit radiation. FDA also has responsibility for regulating the manufacturing, marketing and distribution of tobacco products to protect the public health and to reduce tobacco use by minors. 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. Increased development of research, education and outreach partnerships within the VHA will greatly contribute to FDA’s mission.
VA Ventures is part of the Office of Healthcare Innovation and Learning (OHIL), under Discovery, Education and Affiliate Networks (DEAN). VA Ventures’ vision is a future in which any Veteran can walk into any VA facility and receive health care solutions that are designed and personalized for Veterans. We will achieve this by building the infrastructure necessary to bring prototyping and product development back within our hospital walls, where VHA health care providers, along with inter-agency governmental partners such as the FDA, can ensure that patients’ needs, safety and health outcomes are being addressed. VA Ventures supports the next generation of innovators and ideas by serving as the epicenter for medical device development and market release. By housing government, academia and industry partners under one roof, American medical device development can be accelerated, benefiting Veterans as well as the greater American Public.
IV. GOALS OF THE OVERALL COLLABORATION
This collaboration will initially focus on the development of regulatory science tools in the space of interoperability. Interoperability of medical equipment is the gateway to achieving a variety of healthcare advancements in the spaces of automation, telemedicine, and personalized healthcare. This focus will have an impact in addressing medical needs in underserved rural populations as the ability to monitor and treat patients with advanced health care outside the walls of a hospital requires interoperable systems. Communications protocols, methods for data acquisition and processing, and the medical devices and sensors that will be integrated into remote medical systems create significant regulatory questions in the evaluation of the safety and effectiveness of these medical devices. The colocation of staff within FDA’s Center for Devices and Radiological Health, The Office of Science and Engineering Laboratories (CDRH/OSEL) and VA Ventures staff within the VA Ventures Innovation Institute (located in Seattle, WA) will provide a unique environment in which to address these gaps, accelerating Regulatory Science Tools (RST) development. The goal of this MOU is to provide a mechanism for the Parties to collaborate directly on RST development and share information, resources, and subject matter expertise.
V. RESPONSIBILITIES OF THE PARTIES
All Parties will:
- Create, test, and refine RSTs for emerging technologies. Projects for specific RSTs will be documented in written form, with timelines, milestones, and protocols that are agreed to by both Parties. All necessary VA and FDA sign-offs will be obtained prior to project launch, including (if applicable) VA ISSO and VA Privacy Office Approval, VA IRB approval, VA Office of Information Technology approval, equivalent functions within the FDA, and local hospital leadership approval. VA will inform FDA before final approvals of any projects involving hospital research participants, so supplemental agreements can be established to address obligations and rights of the non-federal organization, including those related to access to non-public information, intellectual property, and conflict of interest. Any projects requiring shared inter- agency funding will fall under VA OGC Procurement Law Group’s and FDA’s Office of Acquisition and Grants Services’ purview for review. Similarly, any information being made public will be subject to FDA clearance procedures.
- Establish a steering committee to oversee the partnership, ensure compliance with this agreement, and monitor progress of the RST developments. The steering committee will be comprised of 3 members each from FDA and VHA and will meet biannually.
- Create and disseminate training materials aimed at the general public and the MedTech community to increase understanding and adoption of RSTs in technology and product development.
- Provide regular progress reports to the FDA/ VHA Steering Committee.
- Share resources, instructions, and information with the FDA. This includes access to medical device equipment in both test and clinical environments, access to prototyping equipment and materials, and access to health care workers and patients after appropriate vetting through VHA quality improvement and/or Institutional Review Board pathways. All projects encompassed within this MOU will undergo VA ISSO and VA Privacy Office review before launch.
- Provide office, laboratory and prototyping space for up to 8 FDA FTE to be on-site daily in Seattle WA for the duration of this MOU, as well as provide temporary conference and collaborative space as needed (up to 6 times per year) for larger gatherings (up to 100 people) at the VA Ventures Innovation Institute, 4575 Texas Way WEST, Seattle WA 98199.
- Obtain medical equipment required for RST development using VA funds. The equipment will be the property of VA, but will be shared with FDA team members for the purposes of carrying out the work proposed in this MOU.
- Host an external-facing website that will showcase the use of RST in medical device development.
- Place up to 4 Full Time Equivalents (FTE) in VA Ventures in Seattle WA in FY23, with the opportunity to expand to 8 FTE in FY24, pending outcomes of initial projects and available funding. These staff will have their permanent duty station at the VA Ventures Innovation Institute but will be hired and managed by FDA. A requirement is that all staff apply for and be granted Without Compensation (WOC) status at VA, have VA badges, access to VA email and computers. All FDA staff will adhere to VA policies, laws, and requirements while working at any VA facility.
- Work with its Human Capital Team (HCT) to ensure compliance with all regular hiring practices, and to classify these positions according to the appropriate security risks and need for clearance. FTEs will receive the usual post-employment Information Technology (IT) and computer security awareness training, which in part aims to mitigate IT security risks and improper use of FDA IT resources. These employees will be subjected to the FDA Intellectual Property policies and requirements that apply to all FDA employees.
- Provide specific direction on regulatory science needs in the regulatory space. The projects currently being proposed for joint development are aligned with many targets of general interest to the medical device community spanning mixed reality application, wearables, 5G communications, and patient in the loop automation. The combined efforts will support the development of RST to help advancements in the global device development community.
- Ensure that RSTs are made publicly available as appropriate.
- Provide regulatory input as appropriate.
VI. GENERAL PROVISIONS
This is an internal government agreement between FDA and VA and does not confer any rights or benefits to any person or Parties.
To the extent any confidential or other non-public information will be shared pursuant to this MOU, then any such written request submitted to FDA for this information must contain all substantive requirements of 21 C.F.R. § 20.85. Access to the non-public information shared under this MOU shall be restricted to authorized FDA and VHA employees, agents, and officials who require access to perform their official duties in accordance with the uses of the information as authorized in this MOU, unless authorized in writing by the agency that provided the information or otherwise required by law. Such personnel shall be advised of (1) the confidential nature of the information; (2) safeguards against unauthorized disclosure of confidential information, and (3) the administrative, civil, and criminal penalties contained in applicable Federal laws for the unauthorized disclosure of confidential information.
VHA and FDA each agree to clearly identify any such confidential information disclosed in writing; and to clearly memorialize in writing, within a reasonable time, any confidential information initially disclosed orally. The Parties agree not to disclose, copy, reproduce or otherwise make available in any form whatsoever to any other person, firm, corporation, partnership, association or other entity information designated as proprietary or confidential information without consent of the other Party except as such information is subject to disclosure under the Freedom of Information Act (5 U.S.C. § 552) and FDA’s regulations at 21 C.F.R. Part 20, or as otherwise authorized or required by law.
If an agency that has received information under this MOU receives a Freedom of Information Act request for which there are responsive records that originated with the other agency, to the extent practicable, it will refer that request to the other agency for it to respond directly to the requestor regarding the releasability of the information. In such cases, the agency making the referral will notify the requestor that a referral has been made and that a response will issue directly from the other agency.
Proper safeguards shall include the adoption of policies and procedures to ensure that the information shared under this MOU shall be used consistent with the Trade Secrets Act [18 U.S.C. § 1905], the Federal Food, Drug, and Cosmetic Act (FDCA) [21 U.S.C. 301 et seq.], the Privacy Act of 1974, as amended [5 U.S.C. § 552a], the Freedom of Information Act [5 U.S.C. § 552], any other applicable Federal law and their implementing regulations. Pursuant to FDCA section 301(j) [21 U.S.C. 331(j)], FDA will not reveal to VHA any method or process which is entitled to protection as a trade secret.
The purpose of sharing this information, resources, and subject matter expertise is to facilitate:
- Accelerating the development, refinement and dissemination of RST geared towards emerging technologies and interoperability, focusing on automation, telemedicine, and personalized healthcare. The colocation of FDA and VHA staff and the sharing of both Parties’ resources will accelerate RST development.
- Creating educational training, meetings, outreach materials, and programs to facilitate the implementation and use of tools and best practices surrounding RST.
- Fostering a culture of inter-governmental collaboration by placing staff from FDA with VHA in a shared federal space.
VII. RESOURCE OBLIGATIONS
This MOU represents the broad outline of the Parties present intent to enter specific agreements for collaborative efforts in areas of mutual interest to FDA and VA. All activities undertaken through the 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. This MOU does not create binding, enforceable obligations against any Party. This MOU and all associated agreements will be subject to the applicable policies, rules, regulations, and statutes under which FDA and VA operate.
The Parties may not endorse or promote products or services offered by or provided by any non-federal entity. Nothing in this MOU constitutes an endorsement by either Party of emerging technology products or manufacturers. The Parties agree not to make statements to the public at workshops and meetings, promotional literature, on their websites or through any other means that imply that the Parties endorse any emerging technology products or manufacturers. The Parties will work together on news stories, press releases, or other forms of external communication. Each Party will have the opportunity to review media created by the other Party at least 7 days in advance of the intended release date and may choose to edit or remove language as needed.
IX. EFFECTIVE DATE, DURATION, TERMINATION, AND REVIEW
This MOU becomes effective upon the signature of authorized representatives of all Parties and remains in effect for a period of 5 years. This MOU may be modified by mutual consent or terminated by any Party. The Parties may consider the development of a new MOU as needed.
Modification/amendments: Any modifications to this MOU must be in writing and signed by each Party’s authorized official.
Termination: Either Party may unilaterally terminate this MOU in writing to the other Party (i) upon thirty (60) calendar days notice to the other Party with or without cause; or (ii) immediately in the event that a federal statute, federal regulation, or respective Party’s policy materially affects this MOU, or upon good cause.
X. POINTS OF CONTACT
The Parties will utilize the following Points of Contact (POCs) throughout the oversight, reporting, and analysis process of this MOU collaboration. The names listed below represent the persons in these assigned roles at the date of signing this MOU. Each Party may change its POC upon written notice to the other Party. Additional staff subject matter expert(s) may be added as needed.
|Role||FDA Representative||VHA Representative|
Zane Arp, PhD
|Dr. Beth Ripley
Deputy Chief, Office of Healthcare
Innovation and Learning
4575 Texas Way WEST
Seattle, WA 98199
|Program Manager||Dorn Carranza, PhD MBA
10903 New Hampshire Ave
Silver Spring MD 20993
|Mr. Joshua Patterson
Director of Strategy
VHA Office of Healthcare Innovation
|Organizational Sponsor||Ed Margerrison, PhD
10903 New Hampshire Ave
Silver Spring MD 20993
(301) 796 0262
|Dr. Ryan Vega
Office of Healthcare Innovation and
810 Vermont Avenue, NW
Washington, DC 20420
Carolyn Clancy, MD
Assistant Under Secretary for Health,
Discovery, Education and Affiliate Networks
Veterans Health Administration
Approving on behalf of the Food and Drug Administration:
Jeffrey Shuren, MD JD
Director, Center for Devices and Radiologic Health
Food and Drug Administration