Devices for the Assessment of Head Injury
CDRH recognizes that head injury is a major source of concern since the presence and severity of a head injury may not be readily assessable. CDRH is committed to working with device researchers and developers to bring safe and effective devices to patients in the US that facilitate the assessment of head injury. The following table highlights medical devices available in the United States that are legally marketed. For more specific descriptions of these devices, their indications for use, and related information, please follow the links to the Premarket Databases shown.