Medical Devices; Ophthalmic Devices; Classification of Nasolacrimal Compression Device
fda-device · Food and Drug Administration · Rule · Published 2016-06-10 · Effective 2016-06-10 · 81 FR 37499
Document
Document number
2016-13788
Federal Register citation
81 FR 37499
CFR reference
21 CFR 886
Type
Rule
Action
Final order.
Category
fda-device
Sub-agency
Food and Drug Administration
Publication date
2016-06-10
Effective date
2016-06-10
HHS docket
Docket No. FDA-2016-N-1308
Abstract
The Food and Drug Administration (FDA) is classifying the nasolacrimal compression device into class I (general controls). The Agency is classifying the device into class I (general controls) in order to provide a reasonable assurance of safety and effectiveness of the device.