FDA Wants To Move Hepatitis B Diagnostics To Class II
The proposed rule would allow tests for hepatitis B to reach market under 510(k)s rather than PMAs, a step the FDA says is justified by the low risk and high utility of the diagnostics.
The proposed rule would allow tests for hepatitis B to reach market under 510(k)s rather than PMAs, a step the FDA says is justified by the low risk and high utility of the diagnostics.