About FDA

Laboratory of Ultrasonics

Laboratory leader: Gerald Harris 301-796-2508 gerald.harris@fda.hhs.gov

Medical ultrasound spans a wide array of diagnostic, therapeutic, and surgical applications, from fetal sonograms, to therapy for injured muscles, to breaking up kidney stones, to reducing the size of uterine fibroids, among many others. An important part of establishing the safety and effectiveness of these devices is acquiring accurate and meaningful pre-clinical performance information. Therefore, to support the regulatory review of these products, the Ultrasonics Laboratory, located in the Division of Solid and Fluid Mechanics, maintains a research program devoted to exposure measurement and analysis, computational modeling, and guidance and standards development.

An important area of laboratory activity concerns the evaluation of thermal safety for medical ultrasound devices. When ultrasound is sent into the body, it is absorbed and heat is produced. For low intensity diagnostic procedures the temperature rise caused by the ultrasound is minimal. However, for some therapeutic and surgical applications, the devices generate higher intensities to produce deep heating for faster healing of injured tissues, or, at still higher intensities, to destroy tissues such as benign or malignant tumors or control blood loss via thermal ablation. This last application is often called high intensity focused ultrasound (HIFU) surgery. Unlike some of the other medical applications of ultrasound, no guidance or standards documents have been developed for HIFU, although standards organizations are making progress.

To help in the development of standards and to assist CDRH in carrying out its regulatory responsibilities for HIFU devices, the laboratory is developing test methods and computational techniques for analyzing the safety and effectiveness of ultrasound ablation devices. Further, the laboratory has begun studies into the neurological effects of blast waves. Recent accomplishments are presented below, along with a list of relevant publications and presentations by laboratory staff.

Page Last Updated: 11/03/2014
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.