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21 February 2008 Regulatory perspectives and research activities at the FDA on the use of phantoms with in vivo diagnostic devices
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Abstract
For a number of years, phantoms have been used to optimize device parameters and validate performance in the primary medical imaging modalities (CT, MRI, PET/SPECT, ultrasound). Furthermore, the FDA under the Mammography Quality Standards Act (MQSA) requires image quality evaluation of mammography systems using FDA-approved phantoms. The oldest quantitative optical diagnostic technology, pulse oximetry, also benefits from the use of active phantoms known as patient simulators to validate certain performance characteristics under different clinically-relevant conditions. As such, guidance provided by the FDA to its staff and to industry on the contents of pre-market notification and approval submissions includes suggestions on how to incorporate the appropriate phantoms in establishing device effectiveness. Research at the FDA supports regulatory statements on the use of phantoms by investigating how phantoms can be designed, characterized, and utilized to determine critical device performance characteristics. These examples provide a model for how novel techniques in the rapidly growing field of optical diagnostics can use phantoms during pre- and post-market regulatory testing.
© (2008) COPYRIGHT Society of Photo-Optical Instrumentation Engineers (SPIE). Downloading of the abstract is permitted for personal use only.
Anant Agrawal, Marios A. Gavrielides, Sandy Weininger, Kish Chakrabarti, and Joshua Pfefer "Regulatory perspectives and research activities at the FDA on the use of phantoms with in vivo diagnostic devices", Proc. SPIE 6870, Design and Performance Validation of Phantoms Used in Conjunction with Optical Measurements of Tissue, 687005 (21 February 2008); https://doi.org/10.1117/12.768537
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