Medical Devices; General and Plastic Surgery Devices; Classification of the Internal Tissue Marker
fda-device · Food and Drug Administration · Rule · Published 2015-08-05 · Effective 2015-08-05 · 80 FR 46485
Document
Document number
2015-19177
Federal Register citation
80 FR 46485
CFR reference
21 CFR 878
Type
Rule
Action
Final order.
Category
fda-device
Sub-agency
Food and Drug Administration
Publication date
2015-08-05
Effective date
2015-08-05
HHS docket
Docket No. FDA-2015-N-2457
Abstract
The Food and Drug Administration (FDA) is classifying the internal tissue marker 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 internal tissue marker'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.