Office of Strategic Partnerships and Technology Innovation Also referred to as: OST
Suzanne Schwartz, MD, MBA
Director, Office of Strategic
Partnerships and Technology
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 CDRH 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 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 innovation, safety, effectiveness, and quality of medical devices and the safety of radiation-emitting products.
- Provide leadership and facilitate collaboration in fostering the development of medical devices to respond to unmet public health needs and to address challenges of bringing innovative medical devices to market that are safe, effective and high quality.
- Provide leadership and strategic direction on medical device cybersecurity, software, and digital health, including the Software Pre-certification program.
- Provide leadership, oversight, and coordination for CDRH in matters relating to public health emergency preparedness and response activities involving CDRH-regulated products or facilities.
- Provide world-wide leadership in standards implementation and use for medical device innovation and manufacturing, and radiation-emitting product safety.
- Direct and oversee the Center's data, technology, and IT transformation services to ensure effective design, development, and utilization of information systems, electronic data and analytic capabilities to optimize regulatory business processes.
- Office of Strategic Partnership and Technology Innovation
Division of All Hazards Response, Science and Strategic Partnerships
Who We Are
The Division of All Hazards Response, Science and Strategic Partnerships within the Office of Strategic Partnerships and Technology Innovation at CDRH. The teams currently within this division are:
- All Hazards Readiness, Response, and Cybersecurity (ARC)
- Partnerships to Advance Innovation and Regulatory Science (PAIRS)
- Patient Science and Engagement (PSE)
- Standards and Conformity Assessment (S-CAP)
- Science and Special Projects Incubator (SSPI)
What We Do
- Advance national preparedness, response and coordination for all hazards threats, including: chemical, biological, radiological, nuclear, explosive (CBRNE), emerging infectious diseases, natural disasters and cybersecurity incidents involving medical devices by enhancing collaborations, optimizing operational responsiveness and leveraging CDRH's regulatory science capabilities via an integrated approach.
- Lead and collaboratively advance the cybersecurity posture of the Healthcare and Public Health (HPH) critical infrastructure medical device ecosystem via a total product lifecycle (TPLC) approach, furthering the development and implementation of policy and strategic engagements.
- Expand the breadth and depth of regulatory science knowledge and expertise that will inform safety and effectiveness evaluation of medical countermeasure (MCM) assets critical for deployment before and during a public health incident, the All-hazards Readiness, Response and Cybersecurity (ARC) program facilitates the timely review of all MCM medical devices and diagnostics in CDRH's MCM portfolio.
- Enhance consensus standards and their use in the design, development, and evaluation of medical devices across their lifespan by producing and implementing clear policies to promote the appropriate use of standards in regulatory processes.
- Anticipate the need for and lead development of national and international consensus standards, advance initiatives to increase confidence in conformity assessment activities, and provide leadership in standards quality and utilization through outreach and global harmonization.
- Develop, foster, and advance partnerships with patient organizations, health care professional organizations, industry, science and other external organizations to support broad national and international patient-focused and regulatory science programs and activities related to the safety, effectiveness, and quality of medical devices and radiation emitting products.
- Lead CDRH initiatives to advance patient engagement and input in regulatory decisions and actions. The Patient Science and Engagement (PSE) Program advances the adoption and science of patient input in critical areas such as patient reported outcomes (PRO) and patient preference information (PPI).
- Manage the Agency's Patient Engagement Advisory Committee (PEAC).
- Lead CDRH initiatives to advance the health and well-being of children and special populations by fostering innovative systems and collaborations that enhance the medical device ecosystem.
- Provide leadership on medical device-related health of women (HoW) issues, including sex-specific evaluation in clinical studies, and sex/gender-specific questions in medical device related research.
- Manage and provide support to special projects involving emerging or current Center priorities and initiatives at all stages from development through implementation.
- Manage Center programs used by internal customers, including the Center Science Council, regulatory science, MDDTs, Network of Experts, Patient & Caregiver Connection, fellowships, tech transfer, public-private partnerships (e.g. MDIC), and Center-wide working groups.
Division of Digital Health
Who We Are
The Division of Digital Health within the Office of Strategic Partnerships and Technology Innovation at CDRH.
What We Do
- Lead the Digital Health Center of Excellence which is intended to provide an unified and collaborative environment at CDRH for consistently applying best practices, conducting research, support and/or training for software and digital technologies.
- Provide oversight and leadership in the development, review, and implementation of regulations, policies, procedures and guidances related to software and digital health topics, and in the development of new legislation.
- Serve as CDRH's hub on regulatory issues providing advice and assistance on such matters as scope, applicability and meaning of the Federal Food, Drug, and Cosmetic Act law, regulations, and policies affecting software and digital health.
- Oversee, direct, coordinate and monitor consistent application of scientific, technical and policy procedures and activities for all digital health and software topics.
- Develop and establish strategic partnerships with industry groups, health professionals, consumers, and other national and international government agencies for developing and disseminating educational and programmatic information.
- Serve as an expert resource for software and digital health scientific, technical and policy matters by providing advice and consultation to the CDRH Center Director, CDRH offices, and FDA officials including the Office of the Commissioner.
- Address cross-cutting digital health technical, human capital, training and regulatory policy needs of the Center and external stakeholders.
Division of Technology and Data Services
Who We Are
The Division of Technology and Data Services within the Office of Strategic Partnerships and Technology Innovation at CDRH provides oversight of CDRH technology and data capabilities.
What We Do
- Direct and oversee the Center's data, technology, and transformation services to ensure effective design, integration, and utilization of information systems, electronic data, and analytic capabilities to optimize regulatory business processes.
- Provide leadership and direction regarding all aspects of CDRH's data and information technology programs and initiatives including governance, operations, systems management, information security, and strategic portfolio.
- Provide technical evaluations, strategies, and recommendations for new and emerging technologies to ensure CDRH's data and information technology programs can proactively adjust to changing business needs and drivers.
- Develop the architecture, standards, policies, governance, best practices, and road map that best support CDRH information technology and data business priorities.
- Translate and support the data and information technology needs of Center business areas to ensure a successful and seamless customer experience.
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 firstname.lastname@example.org or 800.638.2041 or 301.796.7100.