Date

6-2015

Degree Name

BS in Biomedical Engineering

Department

Biomedical and General Engineering Department

Advisor(s)

Kristen Cardinal

Abstract

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 around these medical devices and is very close to turning in its first 510(k) application to the FDA. The review below was written due to the difficulties that many companies and individuals encounter in approaching the “FDA clearance/approval” process. The goal of the review will be to give a detailed account of the process that G-Force CRC LLC has gone through to date. It will detail the research and writing associated with a traditional 510(k) application, the current status of that application, what I personally learned throughout this process, some of the challenges I encountered, and the next steps for the company.

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