Business · 05/01/2011Updated: 10/17/2026 · 1 min read
FDA Releases Draft Guidance for Lyme Disease Diagnostic Devices
Summary
The US Food and Drug Administration (FDA) has released a draft guidance document outlining recommendations for the development and evaluation of in vitro diagnostic devices for detecting antibodies to Borrelia burgdorferi, the bacteria that causes Lyme disease.
Original source language: Federal Register — Health and Human ServicesOpen original release →