The FDA regulates in vitro diagnostic devices (IVDs) as medical devices. IVDs analyze human samples, such as blood, saliva, tissue and urine. However, in the past, the agency did not use its authority to regulate what are known as “laboratory-developed tests” (LDTs), tests developed and performed at a single laboratory, with all samples sent to that particular lab for testing.
The FDA announced last year that it would henceforth use its medical device regulatory authority to regulate LDTs. This caused a big brouhaha among the labs and others affected by the decision. Genetic testing companies are big players in the LDT market.
And what better way to demonstrate the validity of the FDA’s concerns than the bogus laboratory-developed diagnostic tests used by practitioners of pseudomedicine, such as naturopaths? Results of these tests are used as a pretext to treat diseases and conditions a patient either doesn’t have or doesn’t require treatment.
The regulation is especially critical in light of the current health care practitioner licensing scheme we have in the US (discussed many times on the blog). If the states are not going rein in practitioners — like naturopaths and chiropractors, who have no respect for the scientific method and evidence — then at least the FDA could eliminate some abuse and exploitation of patients by getting rid of the illegitimate tests on which they rely.
Read full, original story: New FDA regulatory role threatens bogus diagnostic tests
