Business · 28/09/2010
FDA Releases Draft Guidance for Herpes Simplex Virus Serological Assays
The Food and Drug Administration (FDA) has made available a draft guidance document outlining the requirements for class II devices that test for herpes simplex virus types 1 and 2, in an effort to ensure compliance with special controls for these devices.
Original source language: Federal Register — Health and Human ServicesOpen original release →