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Today’s Topic: 

Electromagnetic Compatibility (EMC) of Medical Devices – 

Guidance for Industry and Food and Drug Administration Staff 

(For In Vitro Diagnostic (IVD) Submissions) 

February 2, 2023 
Electromagnetic Compatibility (EMC) of Medical Devices - Guidance 

for Industry and Food and Drug Administration Staff

For In Vitro Diagnostic (IVD) Submissions 

Seth J. Seidman 

EMC Program Advisor 

Division of Biomedical Physics 

Office of Science and Engineering Laboratories 

Alberto Buenaventura 

Scientific Reviewer 

Division of Chemistry and Toxicology Devices 

Office of In Vitro Diagnostics (OHT7) 

Center for Devices and Radiological Health 

U.S. Food and Drug Administration
Final Guidance

• Electromagnetic Compatibility (EMC) of 

Medical Devices, issued on June 6, 2022 

– www.fda.gov/regulatory-information/search-fdaguidance-documents/electromagneticcompatibility-emc-medical-devices

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Learning Objectives

• Describe the purpose and scope of the final 

guidance 

• Describe the recommended EMC information 

for premarket submissions, specifically for IVDs 

• Describe an example of how to apply EMC 

recommendations for an IVD submission 

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Purpose and Scope

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Scope of Final Guidance

• Applies to medical devices, including IVD products, and 

accessories that: 

– are electrically powered; or 

– have functions or sensors that are implemented using electrical or 

electronic circuitry. 

6
Implementation Dates

• August 5, 2022 for all device types, except IVDs 

– FDA implemented this guidance 60 days after issuance for 

device types within the scope of this guidance, excluding IVDs 

• June 6, 2023 for IVDs 

– FDA recognizes and anticipates that the Agency and industry 

might need up to 1 year to perform activities to 

operationalize the policies within the guidance for IVDs

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Summary of Changes from 2016 EMC Guidance

• Added more substance and clarity, including for IVDs 

• Organized to follow eSTAR/SMART 

• Specified gaps in recognized standards 

– IEC 60601 - 1 - 2 is a safety standard and has no 

performance/effectiveness requirements 

– Recommendation for testing in both mains and battery modes of 

operation 

– Recommendations for common electromagnetic (EM) emitters not 

addressed in standards 

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EMC Information for Premarket 

Submissions

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EMC - Related Device Characteristics 

and Intended Use Environments

• Device overview 

– Functions/modes, cables, accessories 

• Description of the power supply 

– Mains - powered (i.e., AC) or internally powered (e.g., battery) 

• Intended use environments 

– Professional healthcare facility environment 

– Home healthcare environment 

– Special environment 

• Wireless technology used

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Appendix A – Examples of Typical Medical Device 

Locations within Intended Use Environments

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Professional Healthcare 

Facility Environment

Home Healthcare 

Environment

Special Environment

• Physician offices 

• Outpatient facilities 

• Dental offices 

• Clinics 

• Nursing homes 

• Hospital facilities including 

emergency rooms, patient 

rooms, intensive care, surgery 

rooms, etc., (except areas with 

high-powered medical 

equipment) 

• Limited care facilities

• Surgical centers

• Birthing centers

• Laboratories 

• Personal residences

• Dormitories

• Independent living

retirement homes

• Restaurants and cafes

• Shops, stores, markets

• Cars, buses, trains, boats, 

ambulances

• Office buildings

• Schools

• Churches

• Libraries

• Theaters and stadiums

• Outdoor environments (e.g., 

streets, sidewalks, parks)

 • Medical treatment areas w ith h ig h-

 powered medical equipment 

 - (e.g ., high-frequency surgical 

equipment, short-wave therapy 

equipment, inside the RF 

shielded room of an MRI system)

• Military areas (e.g., submarines, radar 

installations, weapons control systems)

• Heavy industrial areas (e.g., power 

plants, steel and paper mills, foundries, 

automotive and appliance 

manufacturing, smelting and mining 

operations, oil and gas refineries)

• Aircraft environments (e.g., planes, 

helicopters)
Assessment of Medical Device Risks

• Provide a summary description of the risks associated with 

malfunction, disruption, or degradation of the performance of 

the subject medical device due to EM disturbances 

• This summary should categorize the severity of each harm into 

one of the following three levels:

– Deaths and Serious Injuries 

– Non - Serious Adverse Events 

– No Reported or Potential Harm 

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Consensus Standards

• Recommend use of appropriate FDA - recognized consensus 

standards, when applicable 

• If a standard is not FDA - recognized, provide justification 

regarding how the EMC testing performed adequately 

addresses EMC 

• If no consensus standard exists for a certain medical device 

type: 

– Recommend specific EMC testing be performed based on 

foreseeable EM disturbances in the intended use environments 

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Standards for IVDs

• IEC 61326 - 1:2012 and IEC 61326 - 2 - 6:2012 are in the FDA Non - Recognized 

Standards Database 

– www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/nr_results.cfm

• FDA partially recognizes IEC 61326 - 1:2020 and IEC 61326 - 2 - 6:2020 

– www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfstandards/detail.cfm?stan

dard__identification_no=42834

– www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfstandards/detail.cfm?stan

dard__identification_no=42841

• The Supplementary Information Sheets (SIS) for the 2020 versions of IEC 

61326 clarify that the immunity requirements from these standards are not 

FDA recognized

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Partially Recognized Standards

• For IVDs, FDA currently recommends: 

– Using the recognized parts or test methods from the partially 

recognized IEC 61326 standards; and 

– Using acceptance criteria specific to the device’s functions and 

intended use using test levels specified by IEC 60601 - 1 - 2 

• If the next editions of IEC 61326 become fully 

recognized by FDA, then FDA will recommend their use

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Essential Performance (EP) and Immunity 

Pass/Fail Criteria

• IVDs should use acceptance criteria specific to the device's functions and 

intended use 

• EP is most easily understood by considering whether its absence or 

degradation would result in an unacceptable risk, which may be 

accomplished by utilizing acceptance criteria from IEC 60601 - 1 - 2. (i.e., 

essential performance) 

• Pass/Fail criteria can be different for transient vs. continuous phenomena 

• IEC 60601 - 1 - 2 is limited to safety 

– Does not necessarily test that the device is effective or performs as intended 

– Use IEC 60601 - 4 - 2 to assess the immunity of the performance associated with 

the intended use 16
Medical Device Configuration and 

Functions Tested

• Test the device as a system 

– The device should be tested as a system with all medical device 

accessories, components, and subsystems connected and functioning as 

intended. 

– If non - medical equipment is used in a medical system and could affect 

the ability of the medical device to meet the immunity pass/fail criteria, 

the non - medical equipment should also be tested as part of the medical 

device system.

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Medical Device Configuration and 

Functions Tested Continued

• Configure in the device’s intended use 

– Medical device and test or ancillary equipment should be configured in the 

modes and with settings considered to be representative of the medical device’s 

intended use. 

– For example, a medical device that can operate in battery power mode and in 

mains power mode should be tested in both modes. Additionally, batteries with 

embedded electronic circuitry (i.e., smart batteries) that are intended to be 

handled by the user should be removed from the medical device and tested 

separately for immunity to electrostatic discharge due to the potential of 

electrostatic discharge damaging the circuitry of the battery. 

• Wireless technology should be “on” and 

communicating

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Common Electromagnetic (EM) Emitters

• Common EM emitters not adequately addressed by FDA - recognized 

consensus standards are: 

– Radiofrequency identification (RFID) readers, electronic security 

systems (e.g., metal detectors, electronic article surveillance), 

near - field communications (NFC) systems, wireless power transfer 

(WPT), Cellular 5G, and unique medical emitters such as 

electrocautery, MRI, electrosurgical units, and diathermy 

equipment 

• When to Test: 

– “Deaths and Serious Injuries” or “Non - Serious Adverse Events” 

• When labeling is generally an acceptable mitigation: 

– “No Reported or Potential Harm”

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Labeling

• Recommended separation distances and appropriate 

environments of use for which the device is suitable 

• The performance of the device that was determined to 

be essential performance 

• Compliance for each emissions and immunity standard 

• Any deviations or allowances used 

• Specifications required in any standards to which the 

device claims conformity

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Hypothetical IVD Example

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Hypothetical Example 

• An IVD manufacturer of a handheld portable blood analyzer is changing the 

microcontroller unit (MCU) of their FDA - cleared device (chip component) 

• To continue offering products to their customers, the manufacturer 

switched to a different integrated circuit supplier 

• This modification may have a significant impact on the overall safety and 

effectiveness of the IVD as well as on the device's performance and risk profile 

• The modification could also cause compatibility issues between the IVD and its 

parts and/or accessories 

• EMC testing is recommended to determine that the IVD is safe and 

performs as intended

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23

StandardDescriptionSeverity AppliedPerformance Criteria 

allowed under 

IEC 61326-1:2020

IEC 6100-4-8Magnetic Field Immunity50 Hz / 60 Hz, 30 A/m A

IEC 61000 - 4 - 11

IEC 61000-4-11

Voltage Dips of AC lines

Voltage Dips of AC lines

Voltage Dips of AC lines

0% during 1⁄2 cycle

0% during 1 cycle &

70% during 25/35 cycle

B

B

C

• Manufacturer used the FDA partially recognized standard IEC 61326 - 1:2020 in their 

EMC test report 

• However, Clause 6 Immunity Requirements from IEC 61326 - 1:2020 is not recognized 

by FDA per the SIS for IEC 61326 - 1:2020 

• EMC Report would be found deficient due to the use of the unrecognized immunity 

requirements (performance criteria - A,B,C) from IEC 61326-1:2020

Manufacturer’s Response
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Phenomenon Basic EMC 

standard or test 

method

IMMUNITY TEST LEVELS

Professional healthcare 

facility environment

HOME HEALTHCARE 

ENVIRONMENT

RATED power frequency 

magnetic fields 

IEC 61000-4-8 30 A/m 

50 Hz or 60 Hz

Voltage dips IEC 61000-4-11 0 % UT; 0,5 cycle 

At 0°, 45°, 90°, 135°, 180°, 225°, 270° and 315°

0 % UT; 1 cycle and 

70 % UT; 25/30 cycles 

Single phase: at 0°

• EMC test levels from IEC 60601-1-2:2020 recognized by FDA and recommended in the final EMC 

guidance document 

• Test Methods from partially recognized IEC 61326 - 1:2020 and IEC 61326 - 2 - 6:2020, but with an 

acceptance criteria specific to the device's function and intended use; and test levels specified by 

IEC 60601 - 1 - 2 

• Device specific pass/fail criteria that are (1) quantitative, (2) specific to the medical device and 

functions, and (3) observable. 

• These criteria should be determined based on the medical device’s functions, modes, 

indications for use, intended use, and EP (if applicable)

Recommended Approach
Additional Considerations

• Follow the recommendations in the final EMC guidance 

document if submitting an IVD submission after June 6, 

2023 

• EMC testing of an IVD (when applicable) should 

include: 

- A detailed description of the medical device undergoing 

testing, including the configuration, functions, modes, and 

settings that were tested 

- Testing for both mains and battery modes of operation 

- Common EM emitters not addressed in standards

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Other Relevant Guidance

Recommendations in this EMC guidance apply to any new submission. EMC guidance 

recommendations should be considered in conjunction with other applicable guidances. 

• To determine whether a new 510k is required for a modification that may or may not affect 

EMC, refer also to FDA Guidance “Deciding When to Submit a 510(k) for a Change to an Existing 

Device” (www.fda.gov/regulatory-information/search-fda-guidance-documents/deciding-whensubmit -510k-change-existing-device), issued October 25, 2017. 

• To determine whether a modification to one’s own device that may or may not affect EMC is 

appropriate for review as a Special 510(k), refer also to FDA Guidance “The Special 510k 

Program” (www.fda.gov/regulatory-information/search-fda-guidance-documents/special-510kprogram ), issued September 13, 2019. 

• For additional information on reagent changes to an already FDA cleared instrument or assay, 

refer also to “Replacement Reagent and Instrument Family Policy for In Vitro Diagnostic 

Devices” (www.fda.gov/regulatory-information/search-fda-guidance-documents/replacementreagent-and-instrument-family-policy-in-vitro-diagnostic-devices), issued August 17, 2022.

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Summary

• Guidance implementation date for IVDs is June 6, 2023 

• Clarification of EMC expectations for IVDs 

– IEC 61326 - 1:2020 and IEC 61326 - 2 - 6:2020 are partially recognized and the 

immunity requirements from these standards are not FDA recognized 

– Use IEC 61326 for test methods and IEC 60601 - 1 - 2 for test levels 

• Specifies gaps in recognized standards 

– IEC 60601 - 1 - 2 is a safety standard and has no performance/effectiveness 

requirements 

– Test in both mains and battery modes of operation 

– Expectations for common EM emitters not addressed in standards 

• Standards that are fully or partially recognized may be used to evaluate the 

EMC of an IVD device

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Additional Panelist

Yasaman Ardeshirpour 

EMC Program Advisor 

Division of Biomedical Physics 

Office of Science and Engineering Laboratories

Center for Devices and Radiological Health 

U.S. Food and Drug Administration

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Let’s Take Your Questions

• To Ask a Question: 

1. Raise your hand in Zoom 

2. Moderator will announce your name and invite you to ask your question 

3. Unmute yourself when prompted in Zoom to ask your question 

• When Asking a Question: 

• Ask one question only 

• Keep question short 

• No questions about specific submissions 

• After Question is Answered: 

• Mute yourself and lower your hand 

• If you have more questions - raise your hand again

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Thanks for Joining Today!

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• www.fda.gov/Training/CDRHLearn

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