Medical Devices; General Hospital and Personal Use Monitoring Devices; Classification of the Ingestible Event Marker
fda-device · Food and Drug Administration · Rule · Published 2013-05-16 · Effective 2013-06-17 · 78 FR 28733
Document
Document number
2013-11628
Federal Register citation
78 FR 28733
CFR reference
21 CFR 880
Type
Rule
Action
Final order.
Category
fda-device
Sub-agency
Food and Drug Administration
Publication date
2013-05-16
Effective date
2013-06-17
HHS docket
Docket No. FDA-2013-M-0042
Abstract
The Food and Drug Administration (FDA) is classifying the ingestible event marker into class II (special controls). 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.