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FDA Proposes Reclassification of HCV RNA, Antibody Tests

NEW YORK – The US Food and Drug Administration on Wednesday proposed the reclassification of two types of hepatitis C virus (HCV) diagnostic tests from class III to class II, meaning the devices will go through the agency's 510(k) pathway for clearance instead of the more rigorous premarket approval (PMA) pathway if the proposal is finalized.

The two types of tests are nucleic acid-based HCV ribonucleic acid (RNA) devices intended for the detection or genotyping of HCV RNA and certain HCV antibody devices intended for the detection of antibodies to HCV.

The reclassification, if finalized, would "reduce the regulatory burdens associated with these devices," the FDA said in a document. However, class II devices are required to comply with special controls to provide a reasonable assurance of safety and effectiveness.

The agency said it is also proposing that the reclassification uses the names hepatitis C virus (HCV) antibody tests and nucleic acid-based hepatitis C virus (HCV) ribonucleic acid tests. In the current classification, they are named hepatitis C virus antibody assay devices and nucleic acid-based hepatitis C virus ribonucleic acid assay devices.


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