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Office of Strategic Partnerships and Technology Innovation Also referred to as: OST

Effective immediately, the Office of Strategic Partnerships and Technology Innovation (OST) has reorganized to increase organizational capabilities and advance our efforts to meet MDUFA commitments and CDRH’s 2022-2025 Strategic Priorities. For more information, see our office webpages and our FAQ page.

Suzanne Schwartz

Suzanne Schwartz, MD, MBA
Director, Office of Strategic
Partnerships and Technology
Innovation

Who We Are

The Office of Strategic Partnerships and Technology Innovation provides leadership for all scientific collaborative and emerging technology related activities at the Center for Devices and Radiological Health (CDRH).

What We Do

  • Represent the Center for Devices and Radiological Health (CDRH) and collaborates with a broad and diverse array of national and international entities including other government agencies, Congress, industry, academia, consumer and patient organizations, and healthcare professional organizations, with mutual interests in medical devices and radiation-emitting products.  
  • Provide strategic leadership:
    • in advancing partnerships with patient organizations, healthcare professional organizations, industry, scientific and other external organizations to support broad national and international patient-focused and regulatory science programs and activities related to the safety of radiation-emitting products and the safety, effectiveness, quality of, and access to medical devices.
    • in setting strategies to foster the development of medical devices that respond to unmet public health needs, advance health equity, and address challenges of bringing innovative medical devices to market that are safe, effective, and high quality.
    • for medical device cybersecurity, software, and digital health technologies for the Center and the Agency.
    • In the development, recognition, and appropriate use of voluntary consensus standards for medical devices, radiation emitting products and emerging technologies.
    • in coordinating for the Center in matters relating to emergency preparedness and response involving CDRH-regulated products or facilities.
    • for the Center to support resilient medical device supply chains.
  • Provide strategic direction and implementation of CDRH data and technology programs and initiatives.
  • Provide global leadership and set strategy in standards development, implementation and utilization for medical device innovation and manufacturing, and radiation-emitting product safety.
  • Serve as an incubator for new programs and initiatives identified as strategic priorities for the Center and the Food and Drug Administration (FDA).
  • Ensure that these functions and program activities are aligned to the overall strategy and priorities of CDRH and the FDA.

Office Organization

Office of Strategic Partnership and Technology Innovation

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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