News | July 25, 2011

FDA Removes Clearance Requirement for ECG Electrodes

The U.S. Food and Drug Administration (FDA) said it is amending the classification regulation for electrocardiograph (ECG) electrodes into a class II device category, exempting these devices from FDA clearances. This rule is effective as of Aug. 22, 2011.

The move means electrodes will no longer have to meet 510(k) premarket notification requirements. Instead, they will be subject to the new special controls described in the document entitled “Guidance for Industry and Food and Drug Administration Staff: Class II Special Controls Guidance Document:  Electrocardiograph Electrodes.'' As described, the special controls include the following:      

• Documentation of device description, which includes compliance with 21 CFR 820.181(a) to maintain a device master record
• Documentation of performance characteristics, which includes documentation on biocompatibility, electrical performance, adhesive performance, shelf life, reuse, electrodes intended for use in specified procedures, sterility and compliance with 21 CFR part 898
• Specific labeling, including indications for use, cautions, precautions, and adverse reactions.  

Manufacturers must comply with the special controls as identified in the document, either by meeting the recommendations or by some other means that provides equivalent assurance of safety and effectiveness. 

The FDA classifies an ECG electrode as intended to acquire and transmit the electrical signal at the body surface to a processor that produces an ECG or vectorcardiogram.

For more information:

Related Content

ECG Study of NBA Players Shows Need for Sport-Specific Normative Data and Guidelines
News | ECG | December 08, 2017
Cardiologists at NewYork-Presbyterian/Columbia University Irving Medical Center compared electrocardiographic findings...
HeartSciences Announces CE Mark and European Launch of MyoVista High Sensitivity ECG

Just as a Doppler radar color image shows the energy of a storm, MyoVista provides physicians a detailed visual image of the energy distribution during the cardiac cycle.

News | ECG | August 22, 2017
HeartSciences announced the European launch of the MyoVista high sensitivity electrocardiograph (hsECG) Testing Device...
AUM Cardiovascular Receives FDA Approval for CADence ECG Device
Technology | ECG | August 08, 2017
AUM Cardiovascular announced it has received clearance from the U.S. Food and Drug Administration (FDA) for CADence, a...
More Than 20 Percent of Low-Risk Patients Receive Annual ECG
News | ECG | July 20, 2017
July 20, 2017 — More than one in five Ontario patients receive an ...
Heart Test Laboratories, HTL, MyoVista ECG, common stock offering
News | ECG | January 31, 2017
Heart Test Laboratories Inc. (HTL) has successfully raised $12 million by way of a Common Stock private placement...
AirStrip One, ECG management, web client, U.S. clearance
Technology | ECG | October 11, 2016
The U.S. Food and Drug Administration (FDA) has issued 510(K) Class II clearance to a web client for the AirStrip One...
Carestream, Vue Motion universal viewer, ECG waveforms, diagnostic reading, FDA clearance

Image courtesy of Carestream Health

Technology | ECG | November 20, 2015
Carestream has obtained U.S. Food and Drug Administration (FDA) clearance for diagnostic reading of electrocardiogram (...
CardioSecur mobile ECG, 22-lead, 360 degree view of the heart, CardioSecur Pro

Image courtesy of CardioSecur

Technology | ECG | October 08, 2015
Personal MedSystems introduced the first and only 22-lead mobile electrocardiogram (ECG) system, CardioSecur, at the...
Mortara, ELI 280, TouchScreen ECG, ECG advances, new ECG technology

The Mortara Eli 280 is part of a new generation of ECG systems that integrate touchscreen monitors to improve workflow.

Feature | ECG | September 16, 2015 | Dave Fornell
The resting electrocardiogram (ECG) has been us
zebrafish, iWorx Systems Inc., ZS-200 Zebrafish ECG System, cardiac research
Technology | ECG | August 13, 2015
iWorx Systems Inc., developer of advanced physiology teaching and research instruments and software, has introduced a...
Overlay Init