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Today, the U.S. Food and Drug Administration (FDA) is announcing organizational changes within the Center for Devices and Radiological Health (CDRH).
These changes include:
- The creation of new offices within the Office of Product Evaluation and Quality (OPEQ.) The Office of In Vitro Diagnostics and Radiological Health will become two new offices: the Office of Health Technology 7 (OHT7), Office of In Vitro Diagnostics, and the Office of Health Technology 8 (OHT8), Office of Radiological Health. The new structure will provide focused executive leadership and better meet the needs of stakeholder communities with divergent technologies and regulatory requirements.
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- The Office of Clinical Evidence and Analysis (OCEA) has realigned its work from two divisions into three. The newly created Division of Clinical Science and Outreach (DCEA 3) will join the Division of Clinical Policy and Quality (DCEA 1) and the Division of Biostatistics (DCEA 2). The new structure will better align work to help OCEA meet the needs of its internal and external stakeholders.
- The Office of Regulatory Programs (ORP) has created a fourth division, the Division of Regulatory Systems, Tools, and Data Management (DRP 4) to better invest in and support CDRH’s important work in digital transformation, electronic tools and templates, and to grow our market intelligence program.
Questions?
If you have questions about these organizational changes, contact the Division of Industry and Consumer Education.
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