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  6. Office of Technology and Data Services (OTDS)
  1. CDRH Offices

Office of Technology and Data Services (OTDS)

Who We Are

The Office of Technology and Data Services (OTDS) is within CDRH’s Office of Strategic Partnerships and Technology Innovation (OST). This Office provides oversight of CDRH technology and data capabilities. The divisions within this office are:

What We Do

  • Provides strategic leadership for the delivery of modern information technology systems that meets the data needs of the Center while delivering first in class customer service for IT and data needs.
  • Fosters a harmonized CDRH culture for digital transformation and sustainability of business operations and corresponding technical capabilities driven by CDRH’s mission, aligned with Center strategic objectives.
  • Provides leadership, technical evaluations, and direction regarding all aspects of the Center’s data and technology programs and initiatives including governance, operations, systems management, information, security, and strategic portfolio management while being prepared to proactively adapt to changing business needs and drivers.
  • Provides leadership in the development, implementation, and evaluation of the technology and data architecture, standards, policies, governance, best practices, and road map that support the business priorities of the Center.

Division of Business Transformation Delivery (DBTD)

Who We Are

The Division of Business Transformation Delivery leads IT project development to support Center initiatives and leverages analytics to improve the user experience for internal and external CDRH customers.

What We Do

  • Leads the identification and analysis of business operations to identify opportunities for improvement of core business services through IT solutions, translating those needs to solutions aimed to enhance customer experience.
  • Leads the development of projects to support the Center mission and strategic initiatives, assuring quality and value from IT and data assets working collaboratively across FDA.
  • Promote citizen and business-led IT and data development, creating mechanisms that ensure adherence to governance and allow for a smooth transition through initiation, implementation and maintenance of IT and data solutions.

Division of Technology Services (DTS)

Who We Are

The Division of Technology Services (DTS) provides leadership for IT solution identification, development, and implementation within CDRH.

What We Do

  • Drives core technology and infrastructure-related IT solution design from program inception to delivery of requirements to product teams, aligning IT solutions to technical architecture, meeting customer needs.
  • Leads and sponsors coordination of standards-based electronic data submission, storage, retrieval, analysis, and dissemination by collaborating across the CDRH and the Agency.
  • Provides leadership in the development of IT solutions to facilitate the creation and implementation of efficient and effective business solutions, working collaboratively across the Agency, the Center, and with other federal agencies to ensure alignment.
  • Researches, evaluates, and implements informatics solutions in support of the Center’s regulatory mission.

Division of Data Services (DDS)

Who We Are

The Division of Data Services provides leadership for data governance and data initiatives at CDRH.

What We Do

  • Leads data governance for CDRH, fostering data quality and stewardship across the business enterprise.
  • Directs and implements data initiatives including data governance, data harmonization, and data analytics that enable data scientists to address pressing public health challenges related to medical devices.
  • Defines, advocates for, and implements data exchange standards that are consistent with health information technology and the industry.
  • Maintain secure, consistent and high-quality data to enable data-driven decision making with embedded analytics to inform business strategy, fostering data-fueled business growth and development, and advancing strategic initiatives.

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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