Zdrowie i gospodarka · 17/10/2018

FDA Classifies Herpes Virus Nucleic Acid-Based Cutaneous and Mucocutaneous Lesion Panel as Class II Device

The FDA has classified the herpes virus nucleic acid-based cutaneous and mucocutaneous lesion panel as a Class II device, which will provide a reasonable assurance of safety and effectiveness, and is expected to reduce regulatory burdens and enhance patient access to innovative devices.