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  1. Center for Devices and Radiological Health

Division of Partnerships and Innovation

Formerly Partnerships to Advance Innovation and Regulatory Science (PAIRS)

The Center for Devices and Radiological Health's (CDRH) Division of Partnerships and Innovation (DPI) works to ensure U.S. patients and consumers have timely and continued access to safe, effective, and high-quality medical devices through developing and sustaining collaborative partnerships that support innovation and regulatory science advancements.

DPI is in the Office of Equity and Innovative Development (OEID) within CDRH.

What Does the DPI Program Do?

DPI strives to advance regulatory science and public health to support the Center by:

  • Initiating and maintaining strategic collaborations and partnerships that support CDRH's scientific research and communications needs.
  • Supporting CDRH regulatory decision making by acquiring specialized expertise and material resources. By complementing the CDRH's breadth and depth of expertise, DPI enhances the efficiency and effectiveness of CDRH operations.
  • Developing CDRH traineeship programs.
  • Fostering scientific innovation by establishing strategic partnerships with patient organizations, non-profits, academia, private sector organizations, government agencies, and other stakeholders.
  • Facilitating regulatory decision making through qualification of regulatory science tools through the Medical Device Development Tools Program.

DPI Programs:

Regulatory Science Research Programs

Regulatory science is the science of developing tools, standards, and approaches to assess the safety, effectiveness, quality, and performance of products regulated by the FDA. Regulatory science research is vital for enabling CDRH to achieve its mission of assuring that patients and providers have timely and continued access to safe, effective, and high-quality medical devices and safe radiation-emitting products. The critical knowledge gained through regulatory science research not only serves as the basis for the Center to make science-based decisions, but also helps prepare CDRH for rapidly occurring innovations in the medical device ecosystem.

DPI leads CDRH's participation in programs that support both internal (CDRH) and external (inside and outside of FDA) regulatory science research. Some of these programs include:

Internal regulatory science programs like the CDRH Critical Path and OCS intramural grants bring together researchers, clinicians, reviewers, and other subject matter experts within the FDA to make progress on scientific challenges affecting regulatory review at CDRH.

External regulatory science programs, like Centers of Excellence in Regulatory Science and Innovation (CERSI) and Broad Agency Announcements (BAA), enable CDRH to collaborate with researchers outside of FDA, including academic institutions, clinical care facilities, nonprofits, and device manufacturers, as appropriate or applicable, to address regulatory science challenges affecting the whole medical device ecosystem.

Public-Private Partnerships and Collaborative Communities

Public-Private Partnerships (PPPs) are collaborative groups involving multiple stakeholders, such as patient groups, industry, academia, non-profit organizations, and government agencies, to address crosscutting topics in the medical product ecosystem.

The FDA may join a PPP to support the agency's public health mission and advance regulatory science. These partnerships can bring together the knowledge, skills, and assets necessary to create translational shifts and overall advances in regulatory science that no one stakeholder could otherwise achieve independently. DPI establishes and manages relationships with PPPs to ensure appropriate Center involvement.

DPI also coordinates CDRH's participation in Collaborative Communities. Collaborative Communities are typically continuing forums where public and private sector members proactively work together to achieve common objectives and outcomes, like shared challenges in the medical device ecosystem. They can include diverse, relevant organizations and individuals impacted by a specific topic.

Collaborative communities are convened by interested stakeholders and may exist indefinitely, produce deliverables as needed, and tackle challenges with broad impacts.

Medical Device Student and Fellowship Programs

DPI coordinates traineeships and fellowship programs with external partners for CDRH.

These short and long-term traineeship opportunities provide the opportunity for students and recent graduates to learn about the regulatory process while contributing to targeted projects. Qualified participants benefit from unique experiences working with FDA personnel while helping bring innovative technologies to market.

Trainees from many backgrounds participate in these fellowship programs, including:

  • Undergraduate students interested in medical device development
  • Physicians with clinical or surgical expertise
  • Engineers (biomedical, mechanical, electrical, software, etc.)
  • Those from other scientific disciplines

For more information on current fellowship opportunities, please visit the following web page: Scientific Research Jobs, Fellowships, and Collaborations on Medical Devices.

To learn more about the Student Volunteer Service Program, please visit Student Volunteer Service Program (SVSP).

Technology Transfer

Technology transfer enables collaborations by facilitating the transfer of expertise, technology, materials, equipment, and intellectual property developed under federally funded research and development (R&D).

DPI is the contact point for CDRH Technology Transfer and partnership activities. Activities in this area include:

  • Advising and consulting with staff and principal investigators
  • Determining appropriate partnership mechanisms based on Center needs
  • Guiding collaborations between staff and external entities
  • Developing and executing partnership agreements, including Memoranda of Understanding
  • Fostering communication and providing oversight through the many phases of various types of collaborations

FDA and Center Memoranda of Understanding (MOU)s are listed on FDA Memoranda of Understanding.

Medical Device Development Tools

CDRH's Medical Device Development Tools (MDDT) program facilitates device development and timely evaluation of the safety, effectiveness, and performance of medical devices. The program also promotes innovation by providing a more efficient and predictable means for collecting necessary information to support regulatory submissions and associated decision-making.

The MDDT program is a way for CDRH to qualify tools that medical device sponsors can choose to use in the development and evaluation of medical devices. Examples of tools include:

  • Non-clinical assessment models such as animal or computational models
  • Biomarker tests
  • Clinical outcome assessments, including those collected by digital health technologies

Network of Experts Program

The Network of Experts partners with over 140 professional societies, allowing CDRH staff to engage with external expertise in the areas of science, medicine, and engineering.

The Network of Experts allows the Center to keep pace with cutting edge developments, broaden staff exposure to clinical and scientific viewpoints, and further its understanding of novel scientific issues. The Network of Experts does not request or accept external policy advice or opinions.

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