FDA has proposed to reclassify two types of diagnostic tests for hepatitis C virus (HCV) from Class III to Class II. If the reclassification is finalized, devices of this type may go through FDA’s 510(k) pathway for clearance instead of the premarket approval (PMA) pathway. As Class II devices, the products would be required to comply with special controls to provide a reasonable assurance of safety and effectiveness.
The two types of HCV devices 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 in the Federal Register.
- Certain HCV antibody devices intended for the qualitative detection of antibodies to HCV. Read the HCV Antibody order in the Federal Register.
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.
Hepatitis C virus. Image courtesy FDA.