FDA changes Hepatitis C Devices Categorization

To Support Global efforts to test and treat chronic hepatitis C has received a major boost from the Food and Drug Administration (FDA) after the US-based regulator issued a final order for the reclassification of nucleic acid-based hepatitis C virus (HCV) ribonucleic acid (RNA) devices. (1)

The devices for both qualitative or quantitative detection or genotyping of HCV RNA, previously categorized under postamendments class III devices and bearing product codes MZP and OBF, have now been reclassified under Class II, (general controls and special controls).

However, FDA says it is renaming and codifying the devices under the classification regulation named “nucleic acid-based hepatitis C virus (HCV) ribonucleic acid tests.” (ibid)

“FDA is also identifying the special controls that the Agency believes are necessary to provide a reasonable assurance of safety and effectiveness of these devices,” it said in a statement on November 22, 2021. (ibid)

This review of FDA’s policy on the classification of hepatitis C tests is expected to boost global efforts to reduce the increasing burden of HIV and viral hepatitis infections.

The director of the Office of In-Vitro Diagnostics and Radiological Health in FDA’s Center for Devices and Radiological Health Timothy Stenzel, says the 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.” (2)

FDA explains the 510(k) as “a premarket submission made to FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent, to a legally marketed device.” (ibid)

With the new categorization, medical supplies manufacturers will no longer be required to have a premarket approval application (PMA), that he says is “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,” he says. (ibid)

More HCV test kit manufacturers would now find the playing field easy to enter with the new reclassification hence “increase competition and increase access to these important tests.” (ibid)

Moreover, the reclassifications targets scaling up of the number of patients seeking access to HCV tests hence ensuring more of those infected access to treatment and reduce transmission.

FDA categorizes the HCV diagnostic tests into two groups including those utilizing the nucleic acid-based HCV ribonucleic acid (RNA) devices specifically for qualitative or quantitative detection or genotyping of HCV RNA. The other group comprise of HCV antibody devices that tests the quality as opposed to the quantity of the HCV in blood, urine or saliva.

This reclassification of the hepatitis C test by FDA comes nearly three years after global pioneer in pharmaceuticals and diagnostics Roche, announced a new Global Access Program that would incorporate Mycobacterium tuberculosis (MTB), Hepatitis B and C (HBV and HCV), especially in low-income countries such as in Africa and Asia “where the disease burden is the highest.” (3)

 “With effective treatment options for these infectious agents and improved patients access to diagnostics, early detection can help save lives and ease suffering,” said Michael Heuer, CEO Roche Diagnostics. (ibid)

Other leading hepatitis diagnostic test kit manufacturers include, Abbott Laboratories, bioMérieux SA, Bio-Rad Laboratories Inc., QIAGEN, Hologic Inc., Meridian Bioscience, Inc., Maternova, Siemens AG, and Creative Diagnostics. (4)

Meanwhile, WHO has prequalified several companies, including Chinese companies ABON Biopharm, Span Biotech Ltd and InTec Products, to supply the global healthcare system with hepatitis C test kits. (5)

Globally, hepatitis C virus, which causes hepatitis C that inflames the liver, has infected approximately 58 million people with about 1.5 million getting infected annually.

The World Health Organization (WHO) says up to 290,000 people died from hepatitis C in 2019 “mostly from cirrhosis and hepatocellular carcinoma.” (6)

REFERENCES;

1. https://www.federalregister.gov/documents/2021/11/22/2021-25379/microbiology-devices-reclassification-of-nucleic-acid-based-hepatitis-c-virus-ribonucleic-acid-assay

2. https://www.fda.gov/news-events/press-announcements/fda-brief-fda-issues-final-orders-reclassifying-certain-hepatitis-c-diagnostic-tests-class-iii-class

3. https://www.roche.com/investors/updates/inv-update-2019-07-22b.htm

4. https://www.globenewswire.com/news-release/2019/06/18/1870252/34408/en/HIV-HBV-HCV-Test-Kits-Market-Size-Worth-US-9-4-Billion-by-2029-Future-Market-Insights.html

5. https://www.worldhepatitisalliance.org/missing-millions/wp-content/uploads/2020/04/WHO-prequalifications-list-2020.pdf

6. https://www.who.int/news-room/fact-sheets/detail/hepatitis-c

About the Author:

With great honor and pleasure, PharmaSources.com has now invited Shem Oirere as one of the original writers. He graduated from the University of South Africa with a bachelor’s degree in International Relations and Diplomacy and also holds a Diploma in Journalism from the London School of Journalism. He previously worked for the Kenya Times, Nation Media Group and The People Daily over a twenty-year span as a business writer and Sub-editor. He wishes to share a view of the scenes behind Africa's latest pharma market trends with the rest of the world.