FDA releases updated draft guidance for ANA test systems
Device Regulation Alert: Safety, Compliance and Reimbursement News, February 9, 2009
New developments for in vitro diagnostic devices prompted the FDA to release a revised guidance document, “Recommendations for Anti-Nuclear Antibody (ANA) Test System Premarket (510(k)) Submissions.”
This revised guidance applies only to in vitro diagnostic devices that detect anti-nuclear antibodies as an aid in the diagnosis of autoimmune disease, not tests that differentially diagnose autoimmune diseases.
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