For Immediate Release:

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:

“Today’s action 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.

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

Additional Information

  • Today, the FDA issued two final orders, reclassifying certain HCV diagnostic tests from class III to II. These orders allow these HCV tests to use FDA’s 510(k) pathway rather than the PMA pathway.
  • The two types of HCV diagnostic tests being reclassified are nucleic acid-based HCV ribonucleic acid (RNA) devices intended for the qualitative or quantitative detection or genotyping of HCV RNA and certain HCV antibody devices intended for the qualitative detection of HCV.

Related Information

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The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

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