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FDA Reorganizes Its Center for Devices and Radiological Health

by | May 9, 2022 | Articles, News, Open Content

The changes affect the Office of Product Evaluation and Quality’s Office of In Vitro Diagnostics and Radiological Health.

The U.S. Food and Drug Administration announced a series of organizational changes within the Center for Devices and Radiological Health (CDRH), the office that deals directly with new medical devices and laboratory developed tests. The changes affect the Office of Product Evaluation and Quality’s Office of In Vitro Diagnostics and Radiological Health, which will be split into two new offices:

  • The Office of Health Technology 7, Office of In Vitro Diagnostics (OHT7); and
  • The Office of Health Technology 8, Office of Radiological Health (OHT8).

Meanwhile, the Office of Clinical Evidence and Analysis, which is currently made up of two divisions—the Division of Biostatistics and the Division of Clinical Policy and Quality—will be joined by a newly created third division called the Division of Clinical Science and Outreach.

Last but not least, the Office of Regulatory Programs is getting a new fourth division called the Division of Regulatory Systems, Tools, and Data Management.

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