Laboratory Developed Tests: Small Entity Compliance Guide: Guidance for Laboratory Manufacturers and Food and Drug Administration Staff
Information
Type
Guidance
Regulated products
Biologics, Medical Devices
Published
June 25, 2024
Last updated
June 24, 2024
Description
A guidance document for laboratory manufacturers and FDA staff on compliance with regulations for Laboratory Developed Tests (LDTs).
Tags
Organization
Country / Region
United States
License
Other (Public Domain)