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Engineering Commons

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Theses/Dissertations

California Polytechnic State University, San Luis Obispo

2015

Biomedical Engineering

Food and Drug Administration

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Full-Text Articles in Engineering

A Comprehensive Review Of The Food And Drug Administration, The 510(K) Application Process, And Fda Certification For A Diagnostic Device, Taylor Davis Jun 2015

A Comprehensive Review Of The Food And Drug Administration, The 510(K) Application Process, And Fda Certification For A Diagnostic Device, Taylor Davis

Biomedical Engineering

The company G-Force CRC LLC is currently experiencing the dichotomy of the FDA's conflicting role right now as they begin to approach FDA approval. G-Force CRC LLC is a small medical device company headquartered in San Diego, CA. The owner of the company, Dr. Ian Purcell, is an Otoneurologist apart of Alvarado Hospital. His medical practice mainly deals with patients who have balance disorders and therefore the devices that he has developed over the last 6+ years are primarily used to assist in the diagnosis of those balance disorders. G-Force CRC LLC was officially created in the summer of 2013 …