FDA Eases Regulatory Clearance Process for Some Hepatitis C Diagnostic Tests

The FDA has reclassified certain hepatitis C tests to make the regulatory process easier for sponsors.

The reclassification allows sponsors to seek marketing clearance through the less burdensome 510(k) pathway, rather than submitting a more stringent premarket approval application.

The agency said that following reclassification, with adherence to the special controls, the specified hepatitis C tests will continue to provide a reasonable assurance of safety and effectiveness.

The reclassification may also encourage more manufacturers to develop the tests, which would increase competition and access, the agency said.