FDA/CDRH's External Expertise Partnerships (EEP) Program
External Expertise and Partnerships (EEP)
The Center for Devices and Radiological Health (CDRH) regulates a wide array of medical devices. To keep pace with the rapid development of new technology, and to make decisions based on the best scientific information and knowledge available, CDRH routinely collaborates with experts in the academic community, government entities, clinical practice, and industry. External Expertise and Partnerships is located in the Office of the Center Director in CDRH.
EEP's mission is to advance public health by acquiring specialized expertise and material resources that support scientific and clinical evaluations conducted in the offices of CDRH. By filling gaps in expertise for a finite period of time, EEP enhances the efficiency and effectiveness of CDRH operations. EEP is the focal point of all CDRH fellowships and interorganizational partnerships. EEP also fosters scientific innovation by helping offices form partnerships with academia, private sector organizations, and government agencies. The consulting and oversight services facilitate project success and ensure that CDRH employees operate within the context of all legal obligations.
The Medical Device Fellowship Program began at CDRH in 2003 with the goal of advancing public health by acquiring specialized expertise and material resources for a finite period of time in support of scientific and clinical evaluations conducted in the offices of CDRH. The Fellowship Program addresses how to place external expertise for targeted projects.
Fellows are full-time or part-time Food and Drug Administration (FDA) employees. Qualified individuals, including clinicians, scientists, researchers, academics, and students in appropriate fields, enjoy unique experiences working with world-class scientists, physicians, and engineers, while helping bring innovative technologies to market. There are opportunities to present research results through publications and presentations.
EEP coordinates MDFP fellows and projects, as well as the CDRH fellowship projects for the FDA Commissioner’s Fellowship Program (CFP) and the FDA-NCI Interagency Oncology Task Force (IOTF) Fellowship.
Partnership and Technology Transfer refers to the processes involved in facilitating the transfer of expertise, technology, materials, equipment, and intellectual property. The activities in this area include: advising and consulting with appropriate staff and principal investigators (PIs), determining partnership mechanisms, guiding collaborations, developing and executing partnership tools, fostering communication, and providing oversight through the many phases of collaborations. EEP is the contact point for CDRH Technology Transfer and partnership activities.
Technology transfer has been defined by the Federal Laboratory Consortium for Technology Transfer as follows:
“Technology transfer is the process by which existing knowledge, facilities, or capabilities, developed under federal research and development (R&D) funding, are used to fulfill public and private needs.”
This list is a general overview of technology transfer mechanisms that serve as partnership tools:
Confidential Disclosure Agreements (CDAs)
Provide protection against disclosure of proprietary information
Material Transfer Agreements (MTAs)
Are simple agreements between government, academic, or private sector partners (industry or professional societies)
Permit the transfer of disposable equipment, supplies, materials, or proprietary data or information that is trade secret
Involve no interactive collaboration
Cooperative Research and Development Agreements (CRADAs)
Provide mutually beneficial collaboration and cooperation between FDA and government, academic, or private sector partners (industry or professional societies)
Enable collaborator to contribute personnel, equipment, materials, or funds
Enable government to contribute personnel, equipment, or materials, but NOT funds
Are funding provided from the government or private sector for a specific project by an application process
Interagency Agreements (IAAs), or IAGs
Are formal agreements between FDA and other Federal agencies
Concern transfer of funds, provision of services, loan of staff, or use of property, facilities, or equipment, or exchange of information (costly)
Memorandums of Understanding (MOUs), also known as Memorandums of Agreement (MOAs)
Represent agreement between two or more government, academic, or private sector partners (including nonprofits, professional societies, etc.)
Establish organizational links in Technology Transfer
Are announced by publication in the Federal Register
The Critical Path Initiative facilitates a national effort to modernize the scientific process through which a potential human drug, biological product, or medical device is transformed from a discovery or “proof of concept” into a medical product. The initiative was launched in 2004 after the release of a report titled Innovation/Stagnation: Challenge and Opportunity on the Critical Path to New Medical Products. The report highlighted the difficulty and unpredictability of medical product development and called for a concerted effort to modernize the scientific tools (e.g., in vitro tests, computer models, qualified biomarkers, innovative study designs) and harness the potential of bioinformation used to evaluate and predict safety, effectiveness, and manufacturability of candidate medical products.
The Critical Path Initiative holds potential to improve the tools FDA uses to evaluate the safety and efficacy of human and veterinarian products and the safety and nutrition of food and food ingredients. In another area, new bioinformatics approaches could greatly enhance the interoperability of information tracking systems in the healthcare environment for all regulated products (e.g., adverse events reporting). As resources allow, FDA will initiate partnerships to address some of these scientific hurdles. EEP coordinates CDRH's Critical Path projects.