US health regulators make it easier to sell hepatitis B tests

The US Food and Drug Administration has reclassified certain hepatitis B virus tests from Class III to Class II. This means manufacturers will face fewer regulatory hurdles and a faster approval process to bring these tests to market.

Before this change, these hepatitis B tests were treated like high-risk medical devices, requiring extensive premarket approval. Now, they are considered moderate-risk, which means a simpler "premarket notification" process. This shift should speed up the availability of new and improved tests for diagnosing hepatitis B.