Home » FDA Eases Regulatory Clearance Process for Some Hepatitis C Diagnostic Tests
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.
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