The FDA’s Center for Devices and Radiological Health (CDRH) is reorganizing to boost organizational agility and advancing its public health mission.

Jeff Shuren, director of CDRH, issued a statement explaining how these changes will support the Center's commitments under the Medical Device User Fee Amendments (MDUFA) V reauthorization and its 2022-2025 strategic priorities.

A key change involves elevating the Office of Communication and Education (OCE) to a Super Office, now named the Office of Communication, Information Disclosure, Training and Education (OCITE). This restructured office will include the Office of Communication and Content Development, the Office of Training and Education, and a new Division of Digital Communication and Marketing.

The Super Office is meant to enhance the dissemination of accurate and meaningful information about CDRH programs to FDA employees, patients, healthcare professionals, and the regulated industry.

Structural changes are also being made within the Office of Product Evaluation and Quality (OPEQ). The Office of Clinical Evidence and Analysis (OCEA) will now consist of five divisions, with the existing Division of Biostatistics expanding into three separate divisions: Biostatistics I, II, and III. These adjustments aim to align work more effectively and support the growing needs of both internal and external stakeholders.

Similarly, the Office of Health Technology 4 (OHT4): Surgical and Infection Control Devices will see the Division of Infection Control and Plastic Surgery Devices split into two distinct divisions: the Division of Plastic and Reconstructive Surgery Devices and the Division of Infection Control Devices. This division will provide more focused leadership and better meet the varying technological and regulatory requirements of these fields.

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