FDA issues guidance on enterovirus nucleic acid assays
Device Regulation Alert: Safety, Compliance and Reimbursement News, January 12, 2009
Any firm that submits a 510(k) for enterovirus nucleic acid assays must show that its device addresses safety and effectiveness concerns identified in new FDA guidance.
An enterovirus nucleic acid assay is intended to amplify and detect enterovirus RNA in human cerebrospinal fluid. The new guidance is designated as a special control. This special control guidance recommends specific information for mitigating risks and covers classification regulations and product codes for enterovirus nucleic acid assays.
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