Medical Devices; Immunology and Microbiology Devices; Classification of Nucleic Acid-Based Devices for the Detection of Mycobacterium Tuberculosis Complex and the Genetic Mutations Associated With Antibiotic Resistance
Information
Type
Rule
Regulated products
IVDMD, Medical Devices
Published
October 22, 2014
Last updated
October 22, 2014
Description
Document number 2014-25049. The Food and Drug Administration (FDA) is classifying nucleic acid-based in vitro diagnostic devices for the detection of Mycobacterium tuberculosis complex (MTB-complex) and the genetic mutations associated with MTB-complex antibiotic resistance in respiratory specimens devices into class II (special controls). The Agency is classifying the device into class II (special controls) because special controls, in addition to general controls, will provide a reasonable assurance of safety and effectiveness of the device.
Tags
Organization
Country / Region
United States
License
Other (Public Domain)