Originally published by our sister publication Pharmacy Practice News
By PPN Staff
Recent steps by the FDA and National Institutes of Health increase the likelihood of point-of-care (POC) testing for hepatitis B virus (HBV) becoming available in the United States, according to the Hepatitis B Foundation.
A proposed rule from the FDA down-classifies HBV screening and diagnostic tests from (high-risk) class III to (moderate-risk) class II devices. This would lower the barriers to entry for