About FDA

Division of Imaging, Diagnostics, and Software Reliability

Phone: (301) 796-2767
Email: CDRH-OSEL-DIDSR-VMAIL@fda.hhs.gov

The Division of Imaging, Diagnostics and Software Reliability (DIDSR) participates in the Center's mission of protecting and promoting public health by identifying and investigating issues related to medical imaging, computer-assisted diagnostics, and software reliability. The division accomplishes this through activities supporting the OSEL mission.

Imaging Digital Pathology

Some examples of research by DIDSR include developing efficient and effective methods for evaluating the image quality of emerging 3-D breast imaging systems; developing methods for characterizing new medical image display devices; evaluating the dose reduction potential of new image reconstruction methods, and assessing whether computer-aided diagnostic devices, intended to improve radiologic interpretation of images, actually provide benefit for tasks such as cancer detection.

DIDSR also develops state-of-the-art methods for the design of clinical trials involving imaging devices and the evaluation of resulting trial data to enable more efficient and effective utilization of imaging data and more powerful clinical studies. Scientists in DIDSR are also engaged in research toward the development and evaluation of tools that may be used to assess software securability and interoperability. These research efforts serve the Center’s mission of advancing regulatory science, facilitating consistent and efficient regulatory pathways, and assuring continued access to safe, effective, and high-quality medical devices.

Specifically, DIDSR focuses on device issues that involve:

  • diagnostic devices,
  • medical imaging systems,
  • radiation-emitting products,
  • general software reliability, and
  • other devices using computer-assisted diagnostic technologies.

DIDSR has expertise in medical imaging, encompassing ionizing and non-ionizing radiation from data capture through image reconstruction, display and observer performance. The computer-assisted diagnostics work of DIDSR is focused on the appropriate mathematical evaluation methodologies for sophisticated computational algorithms used to aid medical practitioners in the interpretation of diagnostic device results.

DIDSR is charged with developing and disseminating performance assessment methodology appropriate to these modalities. DIDSR is also responsible for software reliability and research efforts within OSEL, and research in this area includes software integrity and securability for standalone, mobile and embedded systems.

The technical disciplines of DIDSR staff include physicists, mathematicians, computer scientists, and electrical engineers

The following represent three division areas in DIDSR, each containing research programs:

Page Last Updated: 11/13/2017
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