Zdrowie i gospodarka · 07/02/2020

FDA Classifies HIV Drug Resistance Genotyping Assay Using NGS Technology as Class II Device

The FDA has classified the human immunodeficiency virus (HIV) drug resistance genotyping assay using next generation sequencing (NGS) technology as a Class II device, which will provide a reasonable assurance of safety and effectiveness, and reduce regulatory burdens, ultimately enhancing patients' access to innovative devices.