Cardiovascular Devices; Classification of Electrocardiograph Electrodes
fda-device · Food and Drug Administration · Rule · Published 2011-07-21 · Effective 2011-08-22 · 76 FR 43582
Document
Document number
2011-18391
Federal Register citation
76 FR 43582
CFR reference
21 CFR 870
Type
Rule
Action
Final rule.
Category
fda-device
Sub-agency
Food and Drug Administration
Publication date
2011-07-21
Effective date
2011-08-22
HHS docket
Docket No. FDA-2007-N-0092
Abstract
The Food and Drug Administration (FDA) is classifying the electrocardiograph electrode, intended to acquire and transmit the electrical signal at the body surface to a processor that produces an electrocardiogram (ECG) or vectorcardiogram, into class II (special controls). FDA is also exempting this device from the premarket notification requirement.