About FDA

Laboratory of Optical Diagnostics

Laboratory leader: Joshua Pfefer 301.796.2494 joshua.pfefer@fda.hhs.gov

Novel medical devices employing minimally-invasive optical technologies are making great strides in improving modern health care. While progress is currently most evident in areas such as oximetry, retinal imaging and early detection of mucosal (e.g., gastrointestinal, cervical) cancers, clinical research indicates strong potential for many additional applications including noninvasive glucose sensing and molecular imaging of breast tumors. New optical technologies represent a significant challenge to FDA. For many of these approaches, guidance documents and reliable test methods are currently not available. Basic mechanism data on optical spectroscopy and imaging approaches, including those based on nanoparticles, are needed to identify relevant evaluation criteria early in the regulatory process, thus enabling thorough, swift reviews. Numerical models of light propagation in tissue and phantom-based test methods are also useful tools for elucidating device action and facilitating the device review process. The Optical Diagnostics laboratory works to generate the aforementioned types of data and tools as well as to investigate tissue safety issues for a wide variety of optical devices. This program is located within the Division of Physics (DP).

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