Liotta, Lance A., and Emanuel F. Petrocoin. "Regulatory Approval Pathways for Molecular Diagnostic Technology." Molecular Profiling 823 (2012): 409-20. Springerlink.com. Web.
Diagnostic technology is not just a noninvasive filed, there are many, many, many other forms that operate inside the body ar at the molecular level, such as bloodstream tagging for CT scans or bronchoscopies. These have a rigorous approval process through the FDA, even more so than many of the noninvasive technologies. This article gives a basic overview of the different approval paths that a new technology can follow, and it gives some insight as to all the work that goes into bringing a new technology to market.
Diagnostic technology is not just a noninvasive filed, there are many, many, many other forms that operate inside the body ar at the molecular level, such as bloodstream tagging for CT scans or bronchoscopies. These have a rigorous approval process through the FDA, even more so than many of the noninvasive technologies. This article gives a basic overview of the different approval paths that a new technology can follow, and it gives some insight as to all the work that goes into bringing a new technology to market.
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