CDRH announces reorganization, new communication ‘super office’
The US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) on Monday announced it has elevated its communication office to a new “super office” as part of a move to increase its organizational agility and enable the center to meet its Medical Device User Fee Amendments (MDUFA) V goals as well as its strategic priorities for 2022-2025.Under the reorganization, CDRH is elevating the Office of Communication and Education (OCE) to a super office; the office will be renamed the Office of Communication, Information Disclosure, Training, and Education (OCITE). The office will contain two sub-offices, the Office of Communication and Content Development and the Office of Training and Education, as well as 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,” said CDRH Director Jeff Shuren.
Shuren added that the office will be responsible for delivering “clear, meaningful, insights-based communications, education, and disclosures about medical devices and radiation-emitting products.”
In addition, FDA is also making structural changes within the Office of Product Evaluation and Quality (OPEQ) that will affect both the Office of Clinical Evidence and Analysis (OCEA) and the Office of Health Technology 4 (OHT4): Surgical and Infection Control Devices (OHT4).
Among the changes, OCEA will now be comprised of three new biostatistics divisions: The Division of Biostatistics I, II, and III (DCEA3, DCEA4, and DCEA5, respectively). The other two divisions in OCEA will not be impacted by the reorganization.
The new structure, said Shuren, “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.”
At 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 Division of Infection Control Devices.
Announcement
