Medical Devices; Obstetrical and Gynecological Devices; Classification of the Intravaginal Culture System
fda-device · Food and Drug Administration · Rule · Published 2016-01-06 · Effective 2015-01-06 · 81 FR 378
Document
Document number
2015-33264
Federal Register citation
81 FR 378
CFR reference
21 CFR 884
Type
Rule
Action
Final order.
Category
fda-device
Sub-agency
Food and Drug Administration
Publication date
2016-01-06
Effective date
2015-01-06
HHS docket
Docket No. FDA-2015-N-4408
Abstract
The Food and Drug Administration (FDA) is classifying the intravaginal culture system into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the intravaginal culture system's 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.