Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Reagents for Molecular Diagnostic Instrument Test Systems
Information
Type
Rule
Regulated products
Medical Devices
Published
December 27, 2017
Last updated
December 27, 2017
Description
Document number 2017-27853. The Food and Drug Administration (FDA or we) is classifying the reagents for molecular diagnostic instrument test systems into class I (general controls). We are taking this action because we have determined that classifying the device into class I (general controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.
Tags
Organization
Country / Region
United States
License
Other (Public Domain)