Medical Devices; Hematology and Pathology Devices; Classification of Early Growth Response 1 Gene Fluorescence In-Situ Hybridization Test System for Specimen Characterization
fda-device · Food and Drug Administration · Rule · Published 2014-09-03 · Effective 2014-10-03 · 79 FR 52195
Document
Document number
2014-20882
Federal Register citation
79 FR 52195
CFR reference
21 CFR 864
Type
Rule
Action
Final order.
Category
fda-device
Sub-agency
Food and Drug Administration
Publication date
2014-09-03
Effective date
2014-10-03
HHS docket
Docket No. FDA-2014-N-1176
Abstract
The Food and Drug Administration (FDA) is classifying early growth response 1 (EGR1) gene fluorescence in-situ hybridization (FISH) test system for specimen characterization into class II (special controls). The special controls that will apply to this device are identified in this order and will be part of the codified language for the early growth response 1 (EGR1) gene fluorescence in-site hybridization (FISH) test system for specimen characterization classification. The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.