Zdrowie i gospodarka · 30/10/2017
FDA Classifies Streptococcus SPP Nucleic Acid-Based Assay as Class II Device
The FDA has classified the Streptococcus spp. nucleic acid-based assay into Class II, a category that requires special controls to ensure the device's safety and effectiveness, aiming to enhance patient access to innovative devices while reducing regulatory burdens.
Source: Federal Register — Food and Drug AdministrationOpen original release →