Zdrowie i gospodarka · 03/04/2007

FDA Releases Guidance on Herpes Simplex Virus Serological Assays for Class II Devices

The Food and Drug Administration (FDA) has released a guidance document outlining how serological assays for Herpes Simplex Virus Types 1 and 2 (HSV 1 and 2) can meet the requirements for class II medical devices. This guidance is published in conjunction with a final rule reclassifying these devices from class III to class II, which was also announced by the FDA.