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: www.gpo.gov

Related Content

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 ...
Cardiologs ECG Analysis Platform Receives FDA Clearance
Technology | ECG Monitoring Services| July 13, 2017
Cardiologs Technologies SAS announced that it has received U.S. Food and Drug Administration (FDA) clearance of its...
iRhythm and Stanford Researchers Develop Deep Learning-Based Cardiac Arrhthymia Detection Algorithm
News | Artificial Intelligence| July 11, 2017
iRhythm Technologies Inc. announced a collaboration with the Stanford Machine Learning Group that has resulted in the...
Sponsored Content | Videos | EP Mapping and Imaging Systems| February 01, 2017
This video, provided by Medtronic, demonstrates the CardioInsight electro-anatomical mapping system.
medtronic cardioinsight electromapping system, electoanatomical mapping, noninvasive ep mapping

A screen shot of the waveforms and the the 3-D electo-mapping models created using the noninvasive CardioInsight system.

Technology | EP Mapping and Imaging Systems| February 01, 2017
February 1, 2017 — Medtronic received U.S.
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...
ecg management systems, GE Muse

The latest version of GE’s Muse ECG management system allows integration with other vendors’ ECG, stress testing and Holter monitoring systems.

Feature | ECG Management Systems| January 30, 2017 | Dave Fornell
The movement from paper electrocardiogram (ECG) review to electronic ECG management systems in the past decade has he
ECG, heartbeat, password access, electronic health records, Binghamton University SUNY study, Zhanpeng Jin
News | Electronic Medical Records (EMR)| January 26, 2017
Researchers at Binghamton University, State University of New York have devised a new way to protect personal...
Overlay Init