FDA Seeking Site Visit Proposals for Staff Training
The Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) Experiential Learning Program (ELP) is seeking proposals for CDRH regulatory review staff to visit research, clinical, manufacturing, and health care facilities to observe how medical devices are designed, developed, and used. The FDA explains, "These formal training visits are not intended for FDA to inspect, assess, judge, or perform a regulatory function (e.g., compliance inspection), but rather, they are an opportunity to provide CDRH review staff with a better understanding of the products they review, how they are developed, the voice of the patient, challenges related to quality systems development and management in the product life cycle, and how medical devices fit into the larger healthcare system."
Proposals must be submitted to the FDA no later than Monday, February 24 at 12:00 p.m. EST.
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