Business · 29/08/2001Updated: 10/17/2026 · 1 min read
FDA Releases Draft Guidance for In Vitro HIV Drug Resistance Genotype Assays
Summary
The FDA has made available a draft document outlining special controls for In Vitro HIV Drug Resistance Genotype Assays, which could help manufacturers file 510(k) premarket notifications instead of seeking full premarket approval
Original source language: Federal Register — Food and Drug AdministrationOpen original release →