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FDA UPDATE - SCDRH to Establish New Office to Regulate In Vitro Diagnostic Devices

In the fall of 2002, the Center for Devices and Radiological Health will establish a new office-level organization, called the Office for in Vitro Diagnostic Device Evaluation and Safety. Dr. Steven Gutman has been selected to lead this new organization. This office will introduce both structural and functional changes in the way CDRH regulates in vitro diagnostic devices (IVDs), and is designed to consolidate all premarket, compliance, and postmarket IVD regulatory activity into a single functional unit. The office will operate using a product line focus with a complete integration of all regulatory oversight for this product line in a common unit, and building from a common pool of expertise. The goal of the new office is to develop a seamless and interactive regulatory process consistent with the "total product life cycle." In doing so, CDRH will be able to carry out its statutory regulation in a "least burdensome" manner to protect and promote the public health. It is expected that this new regulatory model will lead to decreased response times for all parts of the regulatory process. While this new organization embodies the concept of the total product life cycle, it is not intended as a step toward broader organizational change.

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