FDA released draft guidance this week on the electromagnetic compatibility (EMC) of medical devices for public comment.
The draft guidance overhauls and significantly expands on the 2016 final guidance it will replace. The agency is using that expansion to share more details on the information medtech companies need to provide to show their devices function in the intended electromagnetic environment.
FDA plans to leverage International Electrotechnical Commission consensus standards, although it notes it has yet to recognize all the standards and as such manufacturers will need to assess if certain standards are appropriate for their devices.
FDA in 2016 published final guidance on the information to support a claim of EMC for electrically powered medical devices. However, the final guidance is very short, with little more than one page used to summarize the information needed to support a claim of EMC. FDA is now offering more detail to help manufacturers show their devices function in electromagnetic environments.
The details of the device and the environment in which it will be used shape the information FDA will ultimately want to see. The agency is advising companies to share a description of the power supplies and wireless technology of their medical devices and a statement about the environments in which they will be used.
That focus reflects the challenges associated with electromagnetism. Medical devices with electrical or electronic functions can malfunction when subjected to disturbances such as radio waves, power surges, radiofrequency and electrostatic discharge. The EMC claim requirement is intended to show the electromagnetic risks associated with a device, based on its characteristics and the disturbances it may encounter where it is used, and to demonstrate the applicant has mitigated the threats.
To demonstrate EMC, FDA is advising companies to provide a summary of the voluntary consensus standards they used to assess the effect of electromagnetism on their devices. If FDA has recognized a consensus standard, the manufacturer should perform the EMC tests using the methods described by the agency.
In some cases, manufacturers may use a consensus standard not recognized by FDA. Manufacturers in that situation should justify their use of the unrecognized standard by showing how the test used addresses EMC for the specific medical device and the environment in which it will be used.
Elsewhere in the draft, FDA discusses the criteria for deciding whether a device has passed or failed an EMC assessment. The criteria differ for transient electromagnetic phenomena, such as voltage dips, and continuous phenomena. It may be acceptable for a device to take time to recover after being exposed to transient electromagnetic phenomena.
FDA is accepting feedback on the draft guidance until Jan. 19, 2021.