Contains Nonbinding Recommendations 
 
Cutaneous Electrodes for Recording 
Purposes  Performance Criteria for 
Safety and Performance Based 
Pathway 
______________________________________________________________________________ 
Guidance for Industry and 
Food and Drug Administration Staff 
 
Document issued on August 14, 2020. 
 
The draft of this document was issued on September 20, 2019. 
 
For questions about this document, contact the DHT5B: Division of Neuromodulation and 
Physical Medicine Devices at 301-796-6610. 
 
 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Devices and Radiological Health 
   Contains Nonbinding Recommendations 
Preface 
 
Public Comment 
 
You may submit electronic comments and suggestions at any time for Agency consideration to 
https://www.regulations.gov. Submit written comments to the Dockets Management Staff, Food 
and Drug Administration, 5630 Fishers Lane, Room 1061, (HFA-305), Rockville, MD 20852. 
Identify all comments with the docket number FDA-2019-D-1649. Comments may not be acted 
upon by the Agency until the document is next revised or updated. 
 
Additional Copies 
 
Additional copies are available from the Internet. You may also send an e-mail request to 
CDRH-Guidance@fda.hhs.gov to receive a copy of the guidance. Please include the document 
number 19014 and complete title of the guidance in the request. 
 
2 
  Contains Nonbinding Recommendations 
Cutaneous Electrodes for Recording 
Purposes  Performance Criteria for 
Safety and Performance Based 
Pathway
 
______________________________________________________________________________ 
Guidance for Industry and 
Food and Drug Administration Staff 
 
This guidance represents the current thinking of the Food and Drug Administration (FDA or 
Agency) on this topic.  It does not establish any rights for any person and is not binding on 
FDA or the public.  You can use an alternative approach if it satisfies the requirements of the 
applicable statutes and regulations.  To discuss an alternative approach, contact the FDA staff 
or Office responsible for this guidance as listed on the title page.  
 
I.  Introduction 
This guidance provides performance criteria for cutaneous electrodes in support of the Safety 
and Performance Based Pathway.1 Under this framework, submitters planning to submit a 510(k) 
using the Safety and Performance Based Pathway for cutaneous electrodes for recording 
purposes will have the option to use the performance criteria proposed in this guidance to 
support substantial equivalence, rather than a direct comparison of the performance of the subject 
device to that of a predicate device. 
 
For the current edition of the FDA-recognized standard(s) referenced in this document, see the 
FDA Recognized Consensus Standards Database.2 For more information regarding use of 
consensus standards in regulatory submissions, please refer to the FDA guidance titled 
Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical 
Devices.3   
 
FDA's guidance documents, including this guidance, do not establish legally enforceable 
responsibilities. Instead, guidances describe the Agencys current thinking on a topic and should 
be viewed only as recommendations, unless specific regulatory or statutory requirements are 
                                                 
1 Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/safety-and-performance-
based-pathway  
2 Available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm  
3 Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/appropriate-use-
voluntary-consensus-standards-premarket-submissions-medical-devices  
3 
  Contains Nonbinding Recommendations 
cited. The use of the word should in Agency guidance means that something is suggested or 
recommended, but not required.  
 
II.  Scope/Device Description 
The cutaneous electrodes that are the subject of this guidance are non-invasive, single use 
electrodes intended to be used on normal, healthy, clean, intact skin for recording purposes. 
These devices are Class II and are regulated under 21 CFR 882.1320, with the product code 
GXY (Electrode, Cutaneous).  
 
Intended Use/Indications for Use: 
The cutaneous electrodes that fall within the scope of this guidance document are intended for 
non-invasive recording purposes only. These devices are intended to be applied directly to a 
patients skin to record physiological signals (e.g., electroencephalogram, electromyography). 
These electrodes should be applied only to normal, intact, clean, and healthy skin with an 
electroconductive media. 
 
Cutaneous electrodes with the following intended uses are not eligible for the Safety and 
Performance Based Pathway via this guidance: 
  To deliver stimulation  
  For use in an MR environment 
  For an intended use regulated by a different regulation (e.g., 21 CFR 870.2360, 21 CFR 
878.4400) 
  To be reused (i.e., not single use) 
  Dry electrodes (i.e., no electroconductive media is used) 
 
Device Design Characteristics:  
The cutaneous electrodes that fall within the scope of this guidance document are designed for 
non-invasive use on intact skin. A cutaneous electrode may incorporate electroconductive media 
(e.g., pre-gelled). If the cutaneous electrode does not incorporate electroconductive media in its 
design, the cutaneous electrode should successfully meet the Testing Performance Criteria 
(described in this guidance) with the legally marketed electroconductive media (21 CFR 
882.1275) intended to be used with electrode. The electrode should be used with 
electroconductive media. Please note that this guidance documents scope does not cover 
electroconductive media devices (21 CFR 882.1275). Additionally, this guidance document does 
not include needle electrodes (21 CFR 882.1350). 
 
The electrode design (e.g., size, shape, type) should be commensurate to the site of application 
and the intended use, as these attributes may affect the safety and effectiveness of the recording. 
Additionally, the size and spacing of the electrodes should be appropriate for the indicated 
patient population (e.g., children, adults). 
 
FDA may determine, on a case-by-case basis, that additional data are necessary to evaluate 
whether the device is appropriate for the Safety and Performance Based Pathway. In situations 
where you determine that additional testing outside of those identified in this guidance are 
necessary to determine whether the device is appropriate for the Safety and Performance Based 
4 
  Contains Nonbinding Recommendations 
Pathway, we would encourage sponsors to submit a Pre-Submission4 to engage in discussion 
with FDA prior to submission of the 510(k).   
 
III.  Testing Performance Criteria 
If your device is appropriate for submission through the Safety and Performance Based Pathway, 
and you choose to use that option, you do not need to provide direct comparison testing against a 
legally marketed predicate device to demonstrate substantially equivalent performance 
characteristics. To ensure that the performance criteria outlined in this guidance remain 
contemporary and take into account relevant data from recent clearances, FDA recommends that 
you provide a results summary for all tests evaluated in addition to the other submission 
information (e.g., Declaration of Conformity (DoC)) identified for each test or evaluation below.  
Unless otherwise identified in the submission information sections below, test information such 
as results summary, test protocols, or complete test reports should be submitted as part of the 
510(k) as described in FDAs guidance Safety and Performance Based Pathway.5 For additional 
information regarding the submission of non-clinical bench testing information, please see 
FDAs guidance Recommended Content and Format of Non-Clinical Bench Performance 
Testing Information in Premarket Submissions.6 
 
Electrode Characterization 
 
1.  Test name: AC Impedance (Electrical Performance)  
Methodology: FDA currently-recognized version of American National Standards 
Institute/Association for the Advancement of Medical Instrumentation (ANSI/AAMI) 
EC12 Disposable ECG Electrodes 
Performance Criteria: 2 kOhms Maximum (Average Value of 10-Hz impedance for 12 
electrode pairs), 3 kOhms Maximum (Individual pair impedance) 
Performance Criteria Source: ANSI/AAMI EC12: 2000/(R)2015 Disposable ECG 
Electrodes 
Submission Information: DoC  
 
2.  Test name: Offset Voltage (Electrical Performance)  
Methodology: ANSI/AAMI EC12 Disposable ECG Electrodes 
Performance Criteria: 100 mV Maximum 
Performance Criteria Source: ANSI/AAMI EC12: 2000/(R)2015 Disposable ECG 
Electrodes 
Submission Information: DoC  
 
3.  Test name: Combined offset instability and internal noise (Electrical Performance)  
Methodology: ANSI/AAMI EC12 Disposable ECG Electrodes 
                                                 
4 Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/requests-feedback-and-
meetings-medical-device-submissions-q-submission-program 
5 Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/safety-and-performance-
based-pathway  
6 Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/recommended-content-
and-format-non-clinical-bench-performance-testing-information-premarket  
5 
  Contains Nonbinding Recommendations 
Performance Criteria: 150 V Maximum 
Performance Criteria Source: ANSI/AAMI EC12: 2000/(R)2015 Disposable ECG 
Electrodes 
Submission Information: DoC  
 
4.  Test name: Bias Current Tolerance (DC Voltage Offset) (Electrical Performance)  
Methodology: ANSI/AAMI EC12 Disposable ECG Electrodes 
Performance Criteria: 100 mV Maximum 
Performance Criteria Source: ANSI/AAMI EC12: 2000/(R)2015 Disposable ECG 
Electrodes 
Submission Information: DoC 
 
5.  Test name: Adhesive Performance  
Methodology: FDA currently-recognized version of International Electrotechnical 
Commission (IEC) 60601-2-2 Medical electrical equipment  Part 2-2: Particular 
requirements for the basic safety and essential performance of high frequency surgical 
equipment and high frequency surgical accessories, (a) Pull Test, (b) Conformability 
Test, (c) Fluid Tolerance Test 
Performance Criteria: (a) No more than 5% of the electrodes adhesive area should 
separate from the skin surface in at least 90% of the tests. (b) No more than 10% of the 
adhesive area of the electrode should have separated from the skin surface at 1 hour after 
application. (c) No more than 10% of the adhesive area of the electrode should have 
separated from the skin surface within 15 minutes after the saline is poured. 
Performance Criteria Source: IEC 60601-2-2 (2016), (a) Pull Test, (b) Conformability 
Test, (c) Fluid Tolerance Test  
Submission Information: DoC  
 
6.  Test name: Shelf Life  
Methodology: Perform electrode characterization tests 1-5 of this guidance document 
(above) with device samples either real-time or accelerated aged to within 30 days of the 
labeled expiration date 
Performance Criteria: Electrode characterization performance criteria identified in tests 
1-5 of this guidance document (above) 
Performance Criteria Source: IEC 60601-2-2 (2016) and ANSI/AAMI EC12: 
2000/(R)2015 Disposable ECG Electrodes 
Submission Information: DoC 
 
If electrode lead wires are included: 
 
7.  Test name: Conductive Connection Compliance (Patient Leads or Patient Cables) 
Methodology: FDA currently-recognized version of ES 60601-1: Medical Electrical 
Equipment  Part 1: General Requirements for Basic Safety and Essential Performance 
Performance Criteria: Conformance to the ES 60601-1 consensus standard 
Performance Criteria Source: ES 60601-1 
Requirement: Percutaneous leads or other cables having a conductive connection to a 
patient must comply with the performance standard in 21 CFR 898.12, which states that 
6 
  Contains Nonbinding Recommendations 
any connector in a cable or electrode lead wire having a conductive connection to a 
patient shall be constructed in such a manner as to comply with subclause 56.3(c) of the 
following standard: International Electrotechnical Commission (IEC) 601-1 Medical 
Electrical Equipment Part 1  General requirements for safety (1988, amendment No.1, 
1991, amendment No. 2, 1995). However, FDA believes conformance to applicable 
subclauses in the currently FDA-recognized version of the ES 60601-1 Medical 
Electrical Equipment Part 1  General requirements for basic safety and essential 
performance (2005, MOD) standard would provide the same level of protection of the 
public health and safety from unintended electrical shock as the FDA performance 
standard in 21 CFR 898.12, and that conformity to this currently FDA-recognized 
standard would be sufficient to meet the performance standard in 21 CFR 
898.12.  Therefore, firms may submit a DoC to this currently FDA-recognized standard.7  
Submission Information: DoC  
 
Biocompatibility Evaluation 
 
To identify the biocompatibility endpoints to include as part of your biocompatibility evaluation 
you should use Attachment A of CDRHs guidance Use of International Standard ISO 10993-1, 
Biological evaluation of medical devices  Part 1: Evaluation and testing within a risk 
management process,8 referred to in the rest of this document as the CDRH Biocompatibility 
Guidance for brevity. FDA considers the devices covered by this guidance to be categorized as 
Surface Devices with intact skin contact, and you should assess the endpoints below per 
Attachment A of the CDRH Biocompatibility Guidance. 
  Cytotoxicity 
  Sensitization 
  Irritation or Intracutaneous Reactivity 
 
Rationale in Lieu of Testing: If the subject device is manufactured from the identical raw 
materials using identical manufacturing processes as a predicate device with the same type and 
duration of tissue contact, and any changes in geometry are not expected to impact the biological 
response, this is typically sufficient to establish substantially equivalent biocompatibility, if 
documentation such as that outlined in Attachment F of the CDRH Biocompatibility Guidance is 
also provided. 
 
Testing: If you determined that testing is needed to address some or all of the identified 
endpoints, FDA recommends that complete test reports be provided for all tests performed unless 
a declaration of conformity without supplemental information can be appropriately provided, per 
Attachment E of the CDRH Biocompatibility Guidance. Any test-specific positive, negative, 
and/or reagent controls should perform as expected, and protocol deviations should be 
thoroughly described and justified; however, note that certain protocol deviations may invalidate 
comparison to the performance criteria listed below and require submission of a Traditional, 
Special, or Abbreviated 510(k). 
 
                                                 
7 See Section 514(c) of Federal Food, Drug and Cosmetic Act.  
8 Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/use-international-
standard-iso-10993-1-biological-evaluation-medical-devices-part-1-evaluation-and  
7 
  Contains Nonbinding Recommendations 
8.  Test name: Biocompatibility endpoints (identified from CDRH Biocompatibility 
Guidance) 
Methodology: FDA currently-recognized versions of biocompatibility consensus 
standards 
Performance Criteria: All direct or indirect tissue contacting components of the device 
and device-specific instruments should be determined to have an acceptable biological 
response. 
Performance Criteria Source: The CDRH Biocompatibility Guidance 
Additional Considerations: For any biocompatibility test samples with an adverse 
biological response, the biocompatibility evaluation should explain why the level of 
toxicity seen is acceptable. Some comparison testing against a legally marketed predicate 
may be necessary (and is considered acceptable under the Safety and Performance Based 
Pathway) to support such a rationale as explained in the CDRH Biocompatibility 
Guidance. For standard biocompatibility test methods that include comparison device 
control samples, the legally marketed comparison device control samples should perform 
as expected, as specified above for the subject device samples. 
Submission Information: Refer to CDRH Biocompatibility Guidance  
8