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  1. CDRH Offices

Office of Equity and Innovative Development


Who We Are

The Office of Equity and Innovative Development (OEID) provides leadership and strategic direction in health equity, patient science, and innovation activities at the Center for Devices and Radiological Health (CDRH). OEID is within CDRH’s Office of Strategic Partnership and Technology Innovation (OST).

What We Do

  • Provide strategic direction to foster health equity and patient-centered development for medical devices.
  • Collaborate across the Office, Center and Agency to develop policies, communication materials, and expertise on complex scientific issues related to patient science as well as diverse, under-represented, and under-served populations.
  • Advance reciprocal partnerships and collaborations with patient organizations, healthcare professional organizations, industry, scientific and other external organizations to support broad national and international programs, address unmet needs, enhance access, and conduct activities focused on medical device-related health equity, patient-centered development, and innovation related to the safety, effectiveness, and quality of medical devices.

Office Organization

Office of Equity and Innovative Development

Division of Patient-Centered Development (formerly Patient Science and Engagement (PSE))

Who We Are

The Division of Patient-Centered Development provides leadership for and advances the Center’s patient-centered initiatives.

What We Do

  • Lead Center initiatives to advance patient-centered development through engaging patients and incorporating their perspectives in medical device regulatory decisions and actions.
  • Advance patient science in critical areas such as patient-reported outcomes (PRO), patient preference information (PPI), and patient generated health data (PGHD), through expertise and collaborative evidence generation and evaluation.
  • Foster reciprocal collaborations and partnerships with patients, caregivers and others to advance patient-centered development for medical devices.

Other links of interest:

Division of Health Equity

Who We Are

The Division of Health Equity provides leadership and strategic direction in health equity for medical device development and fosters innovation in medical device development.

What We Do

  • Advance health equity related to medical device innovation, development, evaluation, patient access and patient safety through strategic initiatives, engagement, research and partnerships.
  • Provide leadership, expertise, and coordination across the Center, Agency, and with external partners to advance evidence generation and enhance communication of medical device-related topics for diverse patient and consumer groups, including but not limited to rare diseases, sex (including health of women), gender, age (including pediatrics), racial, ethnic and geographic groups.
  • Lead strategic initiatives to promote innovation and facilitate device development, evaluation and patient access to innovative technologies

Division of Partnerships and Innovation (formerly Partnership to Advance Innovation and Regulatory Science (PAIRS))

Who We Are

The Division of Partnerships and Innovation helps the center acquire specialized expertise to meet its public health mission through a variety of partnerships.

What We Do

  • Lead the development of collaborative relationships with academic, federal, public and private stakeholders through partnerships, agreements, memoranda of understanding, and other collaborative mechanisms which enable the Center to work with external organizations in support of broad national and international patient-focused and regulatory science programs and activities related to the safety, effectiveness, and quality of medical devices and the safety of radiation-emitting products.
  • Advance medical device regulatory science through management of regulatory science programs and fostering the creation and utilization of medical device development tools in coordination with the Agency, Federal partners, and other stakeholders.

Contact Us

For specific phone numbers and email addresses for each office, division, and team, see the CDRH Management Directory by Organization.

For general questions about medical devices regulation, contact the Division of Industry and Consumer Education at dice@fda.hhs.gov or 800.638.2041 or 301.796.7100.




 
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