FDA to Reclassify Hepatitis B Virus Tests as Moderate Risk Devices

Original from: 360dx

The US Food and Drug Administration said Tuesday that it plans to reclassify several types of qualitative and quantitative hepatitis B virus (HBV) tests as moderate risk Class II devices from their current classification as high-risk Class III devices.

The FDA said on the Federal Register's website that it plans to publish on Sept. 25 a rule for the reclassification. Agency officials said earlier this year that they plan to reclassify most high-risk in vitro diagnostic devices as moderate-risk devices, which would allow 510(k) and de novo marketing authorizations for those devices rather than requiring the more stringent premarket approval. The devices that are reclassified as Class II devices remain subject to special controls including premarket notification and post-market surveillance requirements.

The change announced on Tuesday applies to qualitative HBV antigen assays to aid the diagnosis of acute or chronic hepatitis B virus infection in certain populations, qualitative and quantitative HBV antibody assays, and quantitative HBV assays for the detection of viral nucleic acid in samples from patients with evidence of infection.

The FDA said in its Federal Register notice that it has issued 17 PMAs for HBV antigen assays since 2001, 38 PMAs for HBV antibody assays since 2000, and five PMAs for nucleic acid assays since 2008. It said that the devices had a good safety record with low numbers of adverse events that resulted in patient harm, and the agency thinks that Class II device controls are sufficient to mitigate risks.

The agency noted that the Centers for Disease Control and Prevention estimates between 580,000 and 1.2 million people in the US have chronic HBV infections, and two-thirds of them may be unaware of their infections. The disease can result in liver damage, liver cancer, and liver failure.

While about 95 percent of adults will recover completely from acute infections, the rest develop chronic disease. Children who are born to women with infections are at high risk of infection, and upward of 25 percent of those who develop chronic infection will die of HBV-related hepatocellular carcinoma or cirrhosis.

HBV assays benefit public health by helping to connect infected individuals with antiviral treatments that can suppress the virus and reduce long-term complications and transmission.

Source: FDA to Reclassify Hepatitis B Virus Tests as Moderate Risk Devices