This week, the United States Food and Drug administration provided new information on changes in the Office of In Vitro Diagnostics & Radiological Health. This branch of the FDA was formerly known as the Office of In Vitro Diagnostic Device Evaluation and Safety.
According to a notice by the federal watchdog agency, the new subsection of the Center for Devices & Radiological Health will oversee laboratory and in-home diagnostic tests, radiation-emitting nonmedical products and radiological medical devices. In addition, the subsection will be responsible for the implementation of the federal Mammography Quality Program.
The agency also provided updates in the notice on programs at the Office of Communication, Education & Radiation. According to the FDA, the mission for the group is to “collaboratively support CDRH and the FDA in assuring the safety and effectiveness of medical devices and radiation-emitting electronic products.” The group will implement its mission statement through industry, interagency and public information campaigns.
The text below breaks down the new divisions in the Office of In Vitro Diagnostics and Radiological Health. More information on the new divisions is available at the FDA website, listed below.