LOL
Dumbfuck, that document is not about denying states from making their own LDT's. It's about holding future discussions about if there should be greater oversight of LDT's.
Clearly the FDA is questioning others could produce an LDT that meets their standards. They want it to be entirely under their control.
"Patients and health care providers need accurate, reliable, and clinically valid tests to make good health care decisions. Inaccurate or false test results, or accurate measurements with an invalid claim regarding the test results’ relationship to a disease, can lead to substantial patient harm. LDTs play an increasingly important role in the provision of high-quality health care and many laboratories perform good validation of their LDTs and provide high-quality, professional management of their operations.However, currently, patients and providers cannot uniformly rely on all tests offered for clinical use as some are not subject to active premarket oversight to ensure they provide accurate measurements and valid claims. Furthermore, CMS’ evaluation of clinical utility,as part of a coverage determination, would typically follow from FDA review of analytical and clinical validity.While excessive oversight can discourage innovation, inadequate and inconsistent oversightin which different test developers are treated differentlycan also discourage innovation by making it difficult for high-quality test developers to compete with poorerperforming counterparts.Limited investment and health care funding may be expended on faulty tests rather than focused on tests that lead to improved care. When patients and providers discover that results they relied upon to make treatment and/or diagnostic decisions were inaccurate, their confidence in laboratory testing may be compromised. In arecent example, ovarian cancer screening tests offered to asymptomatic patients were shown not to workonly after patients unnecessarily underwent major surgeries with significant recovery and side effects."
This is how Obama's admin operated. They wanted as much power and control as they could get. Others entities in the bureaucracy could not bypass their regulations. This is what Trump meant when he promised to drain the swamp. We have over regulation like the Paris Climate Treaty agreement that Trump left.
Don't be a sniveling, ground licking, dirt sniffing, low down air head like your words betray you as. What intelligent people should get from this is the FDA needs to relax their standards so other professional agencies can do their jobs and get kits out to the states and public. We do not need another bureaucratic bottleneck in times of crisis. People who want free testing should be able to get it without over regulation. There were huge lines of people in their cars to get the kits when made available. You do not even mention the effects on people who may have the symptoms and are concerned they have COVID-19. Instead, your words expose where your priorities are like the typical Obama followers.
Instead, we should help the medical professionals to do their jobs and keep flattening the curve. The nitty gritty is outlined here -- flattenthecurve.com. These are things that a putz like you do not know about nor consider. This is whay we need another four years of POTUS Trump in order for MAGA to grow and flourish and have a democracy and more streamlined and responsive government. We do not want the socialist, communistic, and fascist ways of the Obama admin throughout our government and society.