Medical Devices; General and Plastic Surgery Devices; Classification of the Absorbable Lung Biopsy Plug
fda-device · Food and Drug Administration · Rule · Published 2014-03-10 · Effective 2014-04-09 · 79 FR 13218
Document
Document number
2014-05061
Federal Register citation
79 FR 13218
CFR reference
21 CFR 878
Type
Rule
Action
Final order.
Category
fda-device
Sub-agency
Food and Drug Administration
Publication date
2014-03-10
Effective date
2014-04-09
HHS docket
Docket No. FDA-2014-N-0107
Abstract
The Food and Drug Administration (FDA) is classifying the absorbable lung biopsy plug 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 absorbable lung biopsy plug'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.