An update from the CDC….

Dec 7, 2021

Dear Colleagues,

 On November 19, the U.S. Food and Drug Administration (FDA) issued final orders reclassifying two types of hepatitis C diagnostic tests from Class III to Class II, thereby allowing manufacturers 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. The two types of hepatitis C virus (HCV) diagnostic tests now reclassified are (1) nucleic acid-based HCV ribonucleic acid devices intended for the qualitative or quantitative detection or genotyping of HCV RNA, and (2) certain HCV antibody devices intended for the qualitative detection of HCV antibodies.

Reclassifying these tests is groundbreaking for hepatitis C diagnostics as it may:

  • Expedite, and in some cases facilitate, bringing methodologies such as rapid nucleic acid tests and potentially antigen detection tests for diagnosis of current HCV infection to the U.S. market 
  • Facilitate development of innovative technologies for point-of-care viral detection assays for diagnosis of current HCV infection
  • Decrease cost, increase competition, and provide smaller companies an opportunity to develop new and improved assays which has the potential to decrease diagnostic device costs
  • Shorten the regulatory approval process time and, thus, decrease turn-around time

Discussions and recommendations regarding reclassification of diagnostic tests for HCV started in 2018 and involved many advisory committees and panels to assess the potential risks, safety, effectiveness, and benefits of the devices if cleared under the proposed Class II special controls. CDC appreciates the work of the FDA to facilitate improvements in HCV diagnostic testing and looks forward to continued work to address the threat of viral hepatitis in the United States. 

This work by the FDA coupled with CDC’s HCV screening recommendations sets the stage to increase hepatitis C testing and linkage to curative treatment, reducing further disease transmission, disease progression, and related deaths. 

More information on the reclassification of HCV diagnostic tests is available at: https://www.fda.gov/news-events/press-announcements/fda-brief-fda-issues-final-orders-reclassifying-certain-hepatitis-c-diagnostic-tests-class-iii-class. 

Thank you,

/Carolyn Wester/

Carolyn Wester, MD

Director, Division of Viral Hepatitis

National Center for HIV, Viral Hepatitis, STD and TB Prevention

Centers for Disease Control and Prevention

www.cdc.gov/hepatitis/

 

/Saleem Kamili/

Saleem Kamili, PhD

Chief, Laboratory Branch

Division of Viral Hepatitis

National Center for HIV/AIDS, Viral Hepatitis, STD and TB Prevention

Centers for Disease Control and Prevention

www.cdc.gov/hepatitis/

 

 /Jonathan Mermin/

Jonathan Mermin, MD, MPH

Rear Admiral and Assistant Surgeon General, USPHS

Director, National Center for HIV, Viral Hepatitis, STD, and TB Prevention

Centers for Disease Control and Prevention

www.cdc.gov/nchhstp