Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of Hemoglobin A1c Test System
fda-device · Food and Drug Administration · Rule · Published 2014-08-25 · Effective 2014-09-24 · 79 FR 50549
Document
Document number
2014-20022
Federal Register citation
79 FR 50549
CFR reference
21 CFR 862
Type
Rule
Action
Final order.
Category
fda-device
Sub-agency
Food and Drug Administration
Publication date
2014-08-25
Effective date
2014-09-24
HHS docket
Docket No. FDA-2014-N-1112
Abstract
The Food and Drug Administration (FDA) is classifying hemoglobin A1c test system 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 hemoglobin A1c test system 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.