EMC of Medical Devices – 510 K Content
For active medical devices, the EMC information is an important part of the 510 K file. Currently the required information is listed on the guidance document “Information to Support a Claim of Electromagnetic Compatibility (EMC) of Electrically-Powered Medical Devices” issued on July 2016. FDA issued recently a draft guidance called “Electromagnetic Compatibility (EMC) of Medical Devices”. Once finalized this new guidance will replace the 2016 guidance and manufacturers should structure the EMC section of their 510 K file according this new guidance. Therefore, it’s worth to review and be familiar with the content of the new guidance document.
As you might recall, the 2016 EMC guidance lists the EMC Information requirements in section II (Paragraphs A to J). These may be summarized as ;
A. The environments defined by the manufacturer for which the medical device is intended to be used,
B. Summary of the testing that was performed to support EMC,
C. The specifications of the standard that were met,
D. A summary of the device-specific pass/fail criteria used,
E. The specific functions of the device that were tested,
F. Specific information about the performance of the device during each test, demonstrating that the device met the emissions and immunity pass/fail criteria,
G. An identification of and a justification for any of the standard’s allowances that were used,
H. A description of and justification for any deviations from the specifications of the referenced standard.
I. The device labeling and evidence of compliance with the reference standard’s labeling (identification, marking and documents) specifications;
J. A detailed description of all changes or modifications that were made to the tested version of the device in order to pass any of the EMC tests.
Main Topics of the New Draft Guidance
Although the new draft guidance includes similar topics under section IV called “EMC Information for Premarket Submissions”, the level of the details included are relatively high. The sub headers (A to K) can be summarized as ,
A. EMC Related Device Characteristics and Intended Use Environments
B. Assessment of Medical Device Risks
C. Consensus Standards
D. Essential Performance and Immunity Pass/Fail Criteria
E. Medical Device Configuration and Functions Tested
F. Results of EMC Testing
G. Allowances
H. Deviations
I. Modifications
J. Common EM Emitters
K. Labeling
Importance of the Risk Assessment
As you can see on the above list the main difference of the new draft guidance is the inclusion of the Risk Evaluation as a separate sub header. Just after definition of the EMC Related Device Characteristics and Intended Use Environments, the guidance directs the manufacturer to assess the risks related to the EMC issues.
Of course the detailed review of the characteristics and intended use environments (Professional Healthcare Facility, Home Healthcare and Special Environment- detailed in Appendix A of the guidance) will improve the effectiveness of the risk assessment which will enable the definition of EMC related specifications and standards.
A 510 K application including the information listed on paragraphs C to K , which are generated according to the results of the risk assessment referred on paraph B, would demonstrate the EMC safety of the concerned medical device easily.
The last section of this draft guidance includes special considerations for the EMC Information to Support an Investigational Device Exemption (IDE) Submission.
If you need detailed information about this topic or support on the EMC evaluation of your medical device, you can contact our experts. We would be happy to help.