Public health is at the forefront of the Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) recent organizational changes, aimed at better positioning the Center to meet its mission to protect and promote public health. Jeff Shuren, M.D., J.D., director of CDRH, announced that these changes are designed to increase organizational agility and advance the Center’s efforts to fulfill commitments under the Medical Device User Fee Amendments (MDUFA) V reauthorization and the 2022-2025 Strategic Priorities.
One of the primary changes involves elevating the Office of Communication and Education (OCE) to a Super Office and creating a new Division of Digital Communication and Marketing. This new structure, now known as the Office of Communication, Information Disclosure, Training and Education (OCITE), will ensure that information about CDRH programs is accurately and readily shared with stakeholders, including FDA employees, patients, healthcare professionals, and the regulated industry. The Super Office will deliver clear, meaningful, and insights-based communications, education, and disclosures about medical devices and radiation-emitting products.
Public Health Focus: CDRH Reorganization Introduces New Offices to Enhance Communication and Training
The OCITE will contain two new sub-offices: the Office of Communication and Content Development and the Office of Training and Education. The reorganization will also establish a new Division of Digital Communication and Marketing. This structure aims to provide increased organizational flexibility and consistency, positioning CDRH to effectively plan for and meet current and future needs.
In addition to changes within OCITE, CDRH is making structural changes within the Office of Product Evaluation and Quality (OPEQ), specifically in the Office of Clinical Evidence and Analysis (OCEA) and the Office of Health Technology 4 (OHT4): Surgical and Infection Control Devices. These changes aim to improve efficiencies and better meet the needs of CDRH’s customers.
The OCEA will now be comprised of five divisions. The Division of Biostatistics will be divided into three new divisions: Division of Biostatistics I, II, and III (DCEA3, DCEA4, and DCEA5, respectively). These changes are intended to align work better, meet the growing needs of internal and external stakeholders, and provide manageable organizational paths to career growth.
In OHT4, the Division of Infection Control and Plastic Surgery Devices will be split into two new divisions: the Division of Plastic and Reconstructive Surgery Devices and the Division of Infection Control Devices. This restructuring will provide focused executive leadership and better meet the needs of customer communities with divergent technologies and regulatory requirements.
Public Health Mission Strengthened: CDRH Enhancements Aim to Improve Access and Address Future Challenges
These organizational enhancements will strengthen CDRH’s ability to serve the American public and ensure that the organization is well-positioned to carry out its public health mission. By creating more focused and flexible structures, CDRH aims to maintain and improve patient access to high-quality, safe, and effective medical devices. The changes will also allow the Center to address current and future challenges more effectively and continue to deliver on its commitments under the MDUFA V reauthorization and its strategic priorities.
CDRH’s elevation of communication and education functions to a Super Office level highlights the importance of effective stakeholder engagement and transparency in advancing public health goals. By enhancing its communication infrastructure, CDRH aims to provide stakeholders with timely and accurate information, fostering a better understanding of regulatory processes and requirements.
Moreover, the reorganization within OPEQ, particularly the changes in OCEA and OHT4, reflects CDRH’s commitment to improving the efficiency and effectiveness of its regulatory oversight. The division of biostatistics into three separate units will allow for more specialized focus and better resource allocation, ultimately enhancing the quality of data analysis and decision-making.
The creation of distinct divisions for Plastic and Reconstructive Surgery Devices and Infection Control Devices within OHT4 will enable more targeted regulatory approaches and executive leadership, ensuring that specific technological and regulatory challenges are addressed more effectively.
In conclusion, the organizational changes announced by CDRH are a strategic move to enhance the Center’s agility and capacity to meet its public health mission. By streamlining its structure and improving communication and operational efficiency, CDRH is better positioned to protect and promote public health through the regulation of medical devices and radiation-emitting products. These changes underscore CDRH’s commitment to advancing public health and ensuring that patients have access to safe, effective, and high-quality medical devices.
Resource: Food and Drug Administration, July 15, 2024
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