"Even before the 2014 draft guidance for LDT, many laboratorians saw the FDA as encroaching on the practice of laboratory medicine."

Ken Gatter, MD, JD (2017) FDA Oversight of Laboratory-Developed Tests: Where Are We Now?. Archives of Pathology & Laboratory Medicine In-Press.

Early Online Release

FDA Oversight of Laboratory-Developed Tests: Where Are We Now?

Ken Gatter, MD, JD

From the Department of Pathology, School of Medicine, Oregon Health Sciences University, Portland.

"Even before the 2014 draft guidance for LDT, many laboratorians saw the FDA as encroaching on the practice of laboratory medicine."

cf., 

http://www.archivesofpathology.org/doi/pdf/10.5858/arpa.2012-0077-ED

and

http://www.archivesofpathology.org/doi/pdf/10.5858/arpa.2013-0020-ED