NEW YORK – The US Food and Drug Administration announced on Friday that it has issued two final orders reclassifying certain hepatitis C diagnostic tests from Class III to Class II. Additionally, it reclassified blood lancet devices from Class I to Class II and Class III.
The change applies to nucleic acid-based hepatitis C ribonucleic acid devices intended for the qualitative or quantitative detection or genotyping of HCV RNA, as well as to certain hepatitis C antibody devices intended for the qualitative detection of the virus.
The orders allow these tests to use the agency's 510(k) clearance pathway instead of the premarket approval pathway, the FDA said in a statement.
The FDA classifies medical devices based on their risk to consumers. Class I devices are considered to be the least risky, while Class III devices are considered to have the highest risk.
"The reclassification may support the potential for more manufacturers to develop these tests, which can increase competition and increase access to these important tests," Timothy Stenzel, director of the Office of In Vitro Diagnostics and Radiological Health at the FDA, said in a statement. "Increased access to tests will likely aid patients in seeking the appropriate treatment and likely reduce transmission."
The FDA also issued two final orders to reclassify blood lancet devices. The agency said that there are three types of lancets intended for use by a single patient. Those lancets are being reclassified from Class I devices to Class II and will require premarket notification, or 510(k) clearance. The FDA said that if these devices have been on the market before the effective date of the final order without an existing 510(k) clearance, it will not enforce the final order for one year, including submission for clearance or special controls.
Another type of lancet, intended for multiple patient use, is being reclassified from Class I devices to Class III and will require a premarket approval application or notice of completion of a product development protocol. Manufacturers of these devices will be required to file a premarket approval application within 30 months from the effective date of the final order.
The reclassifications for the lancets become effective Nov. 22.