FOR IMMEDIATE RELEASE
July 15, 2024

The following is attributed to Jeff Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health (CDRH)

CDRH is pleased to announce new organizational changes to help strengthen and better position the Center to meet our mission to protect and promote the public health. In particular, this new reorganization across offices will increase organizational agility and advance our efforts to meet commitments under the Medical Device User Fee Amendments (MDUFA) V reauthorization, as well as our 2022-2025 Strategic Priorities.

First, CDRH is elevating the Office of Communication and Education (OCE) into a Super Office and creating a new Division of Digital Communication and Marketing. The Super Office designation will allow the Center to assure that information about CDRH programs is accurately and readily shared with our customers, including FDA employees, patients, health care professionals, and regulated industry. The new Super Office will be responsible for delivering clear, meaningful, insights-based communications, education, and disclosures about medical devices and radiation-emitting products.

Key changes:

Office of Communication, Information Disclosure, Training and Education (OCITE)

The new Super Office will be known as the Office of Communication, Information Disclosure, Training and Education (OCITE). The Office will contain two new sub-offices: the Office of Communication and Content Development; and the Office of Training and Education. The reorganization will also create a new Division of Digital Communication and Marketing. This new structure will provide increased organizational flexibility and consistency, and position CDRH to plan for and meet current and future needs more effectively.

In addition, CDRH is making structural changes within the Office of Product Evaluation and Quality (OPEQ) in both the Office of Clinical Evidence and Analysis (OCEA) and the Office of Health Technology 4 (OHT4): Surgical and Infection Control Devices to help improve efficiencies within the offices and better meet the needs of our customers. OCEA provides policy and program support regarding clinical trials, biostatistics, real-world evidence, epidemiological analysis and outreach and collaboration with hospitals and other external stakeholders. OHT4 is responsible for the Total Product Life Cycle (TPLC) review of surgical and infection control medical devices.

Key changes:

Office of Clinical Evidence and Analysis (OCEA)

The Office of Clinical Evidence and Analysis (OCEA), in the Office of Product Evaluation and Quality (OPEQ) will be comprised of five divisions. The Division of Biostatistics will become three new divisions: The Division of Biostatistics I, II, and III (DCEA3, DCEA4, and DCEA5, respectively). The other two Divisions in OCEA are not impacted, other than minor administrative changes. The new structure will better align work and position OCEA and CDRH to meet the growing needs of internal and external stakeholders more effectively while also providing manageable organizational and paths to career growth.

Office of Surgical and Infection Control Devices (OHT4)

The Division of Infection Control and Plastic Surgery Devices will become two new divisions: Division of Plastic and Reconstructive Surgery Devices and Division of Infection Control Devices, which will provide focused executive leadership and better meet the needs of our customer communities with divergent technologies and regulatory requirements.

These organizational changes and enhancements will help strengthen CDRH’s ability to serve the American public and ensure our organization is well-positioned to carry out our public health mission and assure continued patient access to high-quality, safe, and effective medical devices.

Additional Information:

• 2022 – 2025 STRATEGIC PRIORITIES
• Office of Communication, Information Disclosure, Training and Education
• Office of Product Evaluation and Quality
• OCEA: Office of Clinical Evidence and Analysis, Office of Product Evaluation and Quality
• OHT4: Office of Surgical and Infection Control Devices, Office of Product Evaluation and Quality