About FDA

Division of Biomedical Physics

Phone: (301) 796-2580
Email: CRDH-OSEL-DBP-Managers@fda.hhs.gov

The Division of Biomedical Physics (DBP) participates in the Center's mission of protecting and promoting public health by identifying and investigating the biophysical interactions between medical devices and the human body. The division accomplishes this through activities supporting the OSEL mission.

Femtosecond laser tissue interactions Filaments measured during fibrillation

Some examples of research by DBP include investigation of gender-based differences in cardiac resynchronization therapy for pacemakers, development of phantoms (physical models) to assess the measurement of eye disease by optical imaging systems, evaluation and improvement of electrode reliability in neural prosthetics used to control artificial limbs, and computational modeling of active and passive implants to determine if unsafe levels of heating arise during a patient’s exposure to magnetic resonance imaging (MRI) systems. These 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, DBP focuses on device issues that involve:

  • biomedical and tissue optics,
  • biophysics and electrophysiology,
  • electrical engineering,
  • functional device performance and human factors, and
  • wireless communication and electromagnetic interference and compatibility.

DBP has expertise in the diagnostic and therapeutic applications of biomedical optics; biophysics, including cardiac electrophysiology, neuroscience, and functional MRI; computational models; tissue phantoms; electrical engineering, including embedded microprocessor and electronics design, failure analysis, data, signal, and image acquisition and processing; electromagnetics, including MRI implant and electromagnetic compatibility; and functional device performance, encompassing physical medicine, biomechanics, additive manufacturing, and human performance factors.

DBP is charged with developing and evaluating models and methodology to minimize or optimize clinical testing and other types of human exposure to medical devices, developing laboratory test platforms, measurement methods and clinical endpoints, device instrumentation, calibration capabilities, and analytical procedures to characterize and evaluate devices and products in support of the Center’s pre-market and post-market activities.

The technical disciplines of DBP staff include physics, mathematics, biophysics, neuroscience, optics, biomedical engineering, electrical engineering, mechanical engineering, and systems and general engineering
 

Page Last Updated: 03/17/2015
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