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CENTER FOR DEVICES AND RADIOLOGICAL HEALTH (CDRH)

Description:

CDRH develops FDA policy and solves problems related to public health and safety of medical devices and radiation-emitting electronic products. It evaluates applications for premarket approval of medical devices, approves products development protocols and exemption requests for investigational devices. It classifies devices into regulatory categories, develops safety effectiveness standards and good manufacturing practices regulations, operates post market surveillance and compliance programs, and provides technical, non-financial assistance to small manufacturers. The Center also conducts programs to reduce human exposure to hazardous ionizing and nonionizing radiation, through an electronic product radiation control program and other programs designed to control and limit radiation exposure. The Center develops and conducts research and testing programs in the areas of physical, life, and engineering sciences related to the human health effects of radiation and medical device technologies, provides expertise and analyses for health-risk assessments, and also develops new or improved measurement methods, techniques, instruments and analytical procedures for evaluating product performance and reliability.

Research and development opportunities within the FDA that lend themselves to performance by small businesses include, but are not limited to, the following:

A. Examine the setup, documentation and optimization of our Sun Grid Engine (SGE). The architecture of this networking application is particularly suited to managing surge capacity in high performance computing. The modeling of many physiologic functions and bioinformatic analyses can take months or even years to run on a standard desktop computer. The SGE takes the overall problem and distributes it to a cloud of computers on a network so that no user knows, or cares, if a computation is performing in the background on their machine. As FDA rolls out laptops with multi-core CPU's and which are equipped with prodigious amounts memory this experiment in "cloud computing" could become a reality on the Whiteoak Campus. The scope of work would be to develop, document, and provide training systems for developers, network architects, and users on working methodologies for the integration of cloud computing with the existing FISMA compliant conventional networking.

B. Develop a high-speed, low light spectral CMOS linear imaging system to measure complete spectra of multiple variables from living tissue. Complete spectra of fluorescence signals (including auto-fluorescence and FRET) could be measured along a line at high speeds (10 kHz) with a rectangular CMOS grid (e.g. 10 x 1,000 pixels -> 10 sites 1000 wavelengths).

C. Develop bioassays/biosensors to identify injurious levels of nerve stimulation utilizing bioluminescence and neurotransmitter detection technologies. Research capabilities needed include voltage clamp, current clamp and extracellular techniques in peripheral nerves and brain slices to explore stimulation protocols that release neuroactive substances released in injury and inflammation which are not normally evoked under normal physiological conditions.

D. Design, build, and validate a phantom that is traceable to a national metrology institute (NMI) such as NIST (or any other NMI) to improve the accuracy and clinical utility of bone mineral density measurements made using dual energy X-ray absorptiometry (DXA). The calibration phantom should be constructed using biosurrogate materials with known/tabulated data for body tissue and tissue substitutes.

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