FDA Considers Reclassifying Two Hepatitis C Virus Tests

The FDA is proposing to reclassify two Hepatitis C virus diagnostic tests from Class III to Class II.

The agency said it may move the nucleic acid-based HCV RNA tests and certain HCV antibody tests to Class II with special controls to ensure safety and effectiveness.

If the reclassification goes through, the two diagnostics will only require 510(k) clearance before marketing  instead of going through the full premarket approval process.