By: Colleen E. McCarthy
Washington, DC—The U.S. Food and Drug Administration (FDA) recently notified Congress that it intends to issue drafts of guidance documents on lab-developed tests.
The draft guidance is titled “Framework for Regulatory Oversight of Laboratory Developed Tests (LDTs)” and “FDA Notification and Medical Device Reporting for Laboratory Developed Tests (LDTs).”
FDA convenes to discuss updating contact lens guidance
The move comes after several senators called for the White House Office of Management and Budget to release the draft guidance for public comment. Earlier this year, the Centers for Disease Control and Prevention
+++ (CDC) released a notice that a common lab-developed test for Lyme disease commonly results in false-positives.+++
“The draft Framework Guidance proposes a risk-based, phased-in framework for oversight of LDTs in a manner that is consistent with FDA’s current regulation of in vitro diagnostic devices,” says Sally Howard, deputy commissioner for policy, planning, and legislation for the FDA, in a letter to the Senate Committee on Health, Education, Labor, and Pensions.
“The accompanying draft guidance describes the manner in which laboratories may provide notification and comply with medical device adverse event reporting,” Howard wrote.
- See more at: http://optometrytimes.modernmedicine.co ... ZGrls.dpuf
I believe its important to bring this to light considering ISDA's NEW vaccine guidelines for the ImmunoSuppressed:
http://www.pharmacytimes.com/news/Guide ... epth-Guide
NOT taking into consideration the over 95% of the pops infected with Epstein Borreliosis:
"Our combined results show that EBV employs deubiquitination of signaling intermediates in the TLR cascade as a mechanism to counteract innate anti-viral immunity of infected hosts."
Shed antigenic Blebs/Liposomes/exosomes/ or whatever they prefer to call infectious organisms secretions these days. AND the viral fungal/prion protein recombinations that grow with proteins that behave as genes.
Regulation of Toll-like receptor 2 interaction with Ecgp96 controls Escherichia coli K1 invasion of brain endothelial cells. (PMID:22963587) http://europepmc.org/abstract/MED/22963587
THE IDSA/CDC/NIH/FDA/USDA/HHS ARE DIRECTLY RESPONSIBLE FOR AUTISM KIDS SUFFERING AND THE MILLIONS SUFFERING SYNDROMES, PSYCH, AND YES CANCERS THEY CAUSED ADDING TO THE MIX THEY ALREADY GAVE US. JUST AS SURELY AS OVER 8000 US SOLDIERS COMMITTED BRAIN INFECTED SUICIDE , OVER 7000 HAITIANS DEAD FROM INFECTIOUS VACCINES, AND NO TELLING HOW MANY AFRICAN'S WILL FALL FROM ADDING TO THE MIX AND FAILURES TO TREAT THE REAL CAUSE OF AIDS IMMUNE SUPPRESSION.
http://www.lymeneteurope.org/forum/view ... 251#p37251
http://www.accessdata.fda.gov/scripts/c ... fm?ID=3184
They Knew in 1986 and 1981 there were no false positives.
Lyme Test:search box
http://www.accessdata.fda.gov/scripts/c ... /index.cfm
There is no more Normal and yes we all have spirochetal prion protein infections.
Concerns Regarding a New Culture Method for Borrelia burgdorferi Not Approved for the Diagnosis of Lyme Disease
http://www.cdc.gov/mmwr/preview/mmwrhtm ... mm6315a4_w