OVERVIEW OF FDA DRAFT GUIDANCE ON ELECTROMAGNETIC COMPATIBILITY (EMC) OF MEDICAL DEVICES
On November 17, FDA issued a Draft Guidance on Electromagnetic Compatibility (EMC) of Medical Devices. This guidance is intended (once finalized) to supersede the existing guidance, issued in July of 2016, entitled “Information to Support a Claim of Electromagnetic Compatibility (EMC) of Electrically-Powered Medical Devices“.
The existing guidance on the subject of EMC is high level and speaks mostly in terms of generalities regarding the content to be provided in a premarket submission. It would be safe to assume that in the 4.5 years since the issuance of this guidance that there has been significant change in the understanding of appropriate EMC submission content. It would appear that FDA has seen and learned from industry best practices regarding necessary EMC content and how this content should appear in submissions.
A new add to the updated guidance is a section on Assessment of Medical Device Risks. The existing guidance merely references that “Typically, the review of EMC information in a submission is based on the risk associated with EMC malfunction or degradation of the device under review, as well as the use of appropriate FDA-recognized standards or appropriate consensus standards.” Risk was not specifically discussed further in the EMC information to be provided, although it was well understood that risk information is a key component of the 60601 series of standards. The updated guidance goes further and is in alignment with FDAs continued risk assessment as a first step approach toward device review. Summary descriptions of risks are to be provided and the severity of harm should be categorized based upon FDAs existing guidance “Factors to Consider Regarding Benefit-Risk in Medical Device Product Availability, Compliance, and Enforcement Decisions” The risk approach goes beyond what has typically been required in 60601 standards.
FDA has also included a new section related to EMC Information specific to supporting an IDE Submission. There is an acknowledgement that comprehensive EMC testing to consensus standards might not be least burdensome as a device may undergo iterative changes during the course of a clinical trial. FDA indicates that alternate approaches towards demonstrating a favorable benefit/risk determination can be utilized for EMC mitigations. This section is still generally high level, and it would be recommended that any approach using this guidance for an IDE be discussed in detail with FDA utilizing the Pre-Submission process before submitting in a final IDE Submission.
The remaining sections outlined in the updated guidance generally align with the EMC Information requested by the current guidance. However, FDA provides more detail and direction related to what specifics they expect to see and how they expect the information to be provided to them. There will likely be disagreement moving forward on whether or not the new level of detail is enough (or perhaps even too much) for some. FDA tries to walk a fine line between outlining exactly what needs to be included in a submission and establishing an end goal for industry to meet while allowing various pathways to meet that goal. Providing more specifics allows for consistency in review by FDA staff whereas being more general allows for flexibility in approach by industry. In this guidance, it appears as though FDA has tried to split the difference. Due to that approach by FDA, expect to see some changes in the details provided by FDA upon finalization of the guidance.
As mentioned earlier, the information being requested by FDA in this guidance are mostly already included in industry best practices for EMC information provided in submissions. Industry should continue to utilize these best practices and incorporate to whatever degree possible, the additional details requested by FDA in this draft guidance. However, it is likely that some of the details on specific information to be provided will slightly change from the draft version of this guidance to its final version.
