|
Today, the U.S. Food and Drug Administration (FDA) is announcing organizational changes within the Center for Devices and Radiological Health (CDRH) to help strengthen and better position the Center to meet our mission to protect and promote the public health.
First, CDRH is elevating the Office of Communication and Education (OCE) into a Super Office. OCE’s name has changed to the Office of Communication, Information Disclosure, Training and Education (OCITE) to better represent the broad spectrum of their expertise and creating a new Division of Digital Communication and Marketing.
- The new Super Office will be responsible for delivering clear, meaningful, insights-based communications, education, and disclosures about medical devices and radiation-emitting products.
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.
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.
Questions?
If you have questions about thi, contact the Division of Industry and Consumer Education.
|
|
|
|
