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FDA Issues Guidance Doc on Reclassifying NAT TB Tests as 'Moderate Risk'

NEW YORK (GenomeWeb News) – The US Food and Drug Administration has issued a draft guidance suggesting the reclassification of nucleic acid-based tests for detecting tuberculosis from Class III (high risk) to Class II (moderate risk).

The FDA said in a statement released Friday that the proposed rule would encourage the development of nucleic acid-based tests for TB and allow manufacturers to use a "faster, more streamlined clearance pathway for medical devices." The reclassification would apply to NAT in vitro diagnostic devices for detecting Mycobacterium tuberculosis complex (MTB-complex) in respiratory specimens.

The draft guidance details the risks associated with false positive and false negative test results, the risks to health care workers handling specimens, and it provides recommendations on how to mitigate risks.

"The FDA has assessed the risk and benefits of nucleic acid-based diagnostics for TB and believes that we can continue to address their safety and effectiveness through our draft guidance," Alberto Gutierrez, director of the Office of In Vitro Diagnostic Device Evaluation and Safety in FDA's Center for Devices and Radiological Health, said in the statement. "Taken together, these actions will encourage the development of new TB diagnostics while continuing to assure their safety and effectiveness."

The FDA will take public comments on the draft guidance for 90 days, it said.