FDA Issues Final Orders Reclassifying Certain Hepatitis C Diagnostic Tests from Class III to Class II

Food and Drug Administration

WASHINGTON, D.C. — The following quote is attributed to Timothy Stenzel, M.D., Ph.D., director of the Office of In Vitro Diagnostics and Radiological Health in FDA’s Center for Devices and Radiological Health:

“[Reclassifying these Hepatitis C Diagnostic Tests from Class III to Class II] allows manufacturers of certain types of Hepatitis C virus (HCV) tests to seek marketing clearance through the less burdensome premarket notification (510(k)) pathway rather than submitting a premarket approval application (PMA), the most stringent type of FDA medical device review.

“We are confident that following reclassification, with adherence to the special controls, these devices will continue to provide a reasonable assurance of safety and effectiveness. Additionally, the reclassification may support the potential for more manufacturers to develop these tests, which can increase competition and increase access to these important tests.

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“These reclassifications will also benefit the Department of Health and Human Services’ Viral Hepatitis National Strategic Plan, as increased access to tests will likely aid patients in seeking the appropriate treatment and likely reduce transmission.”

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