FDA Proposes to Reclassify Two Types of Hepatitis C Virus Diagnostic Tests

Today, the U.S. Food and Drug Administration (FDA) proposes to reclassify two types of hepatitis C virus (HCV) diagnostic tests from class III to II. If this reclassification is finalized, devices of this type may go through the FDA’s

510(k) pathway for clearance instead of the premarket approval premarket approval (PMA) pathway. As class II devices, these would be required to comply with special controls to provide a reasonable assurance of safety and effectiveness.

The two types of HCV devices the FDA is proposing to reclassify into Class II (special controls) are:

Nucleic acid-based HCV ribonucleic acid (RNA) devices intended for the qualitative or quantitative detection or genotyping of HCV RNA.

Read the HCV RNA Order

Certain HCV antibody devices intended for the qualitative detection of antibodies to HCV.

Read the HCV Antibody Order

Submit comments on these proposed orders

The docket for the proposed orders will be open for public comments for 60 days at www.Regulations.gov:

See docket number FDA-2020-N-1088 to submit comments on Microbiology Devices; Reclassification of Nucleic Acid-Based Hepatitis C Virus Ribonucleic Acid Assay Devices, To Be Renamed Nucleic Acid-Based Hepatitis C Virus Ribonucleic Acid Tests
See docket number FDA-2020-N-1082 to submit comments on Microbiology Devices; Reclassification of Certain Hepatitis C Virus Antibody Assays Devices, To Be Renamed Hepatitis C Virus Antibody Tests

Questions?

If you have questions about these proposed orders, contact Steven Gitterman at Steven.Gitterman@fda.hhs.gov.