June 28, 2023
Anyone visiting a clinic or hospital has seen the electronic equipment on hand. There are medical-record terminals, patient monitors, electrocardiogram (EKG) machines – and that’s what you see without going into an operating room or intensive care unit. Add to that the diagnostic tools that are too numerous to count.
The US Food and Drug Administration (FDA) is responsible for protecting public health by assuring the safety of medical devices, along with that of food, drugs, and cosmetics. Medical devices are usually electronic and need above all else to be safe because of their direct contact with patients’ bodies.
Like any electronic device, each piece of gear emits and is vulnerable to electromagnetic interference (EMI). EMI can be a nuisance with consumer products but can have life-or-death consequences if it causes medical equipment to malfunction. Electromagnetic compatibility (EMC) testing confirms that the device meets published standards to minimize those malfunctions.
Medical devices fall into one of three FDA classifications defined in Title 21, Parts 862-892 of the Code of Federal Regulations (CFR). The three classifications are identified within sixteen medical specialty “panels,” such as Cardiovascular devices or Dental devices. Existing devices are listed within each panel, with its FDA classification identified.
A new medical device in Class I may not require FDA approval, though the manufacturer or importer needs to register with FDA. Class II devices normally require an FDA 510(k) submission requesting clearance to market, based on the device’s equivalence to an existing legally marketed device. A Class III device is used in more critical applications that sustain or support life.
In June 2022, the FDA published a guidance document, “Electromagnetic Compatibility of Medical Devices; Guidance for Industry and Food and Drug Administration Staff.” Premarket submissions to the FDA need to demonstrate EMC for all electrically powered medical devices and those with electronic functions.
The EMC information needed in a premarket submission includes a complete description of the device and its functions, the intended environments where it’s to be used, and descriptions of any wireless functions in the device. The FDA also requires a summary description of the risks associated with malfunctions or disruptions in the device.
The FDA submission needs to include a Declaration of Conformity that shows compliance with EMC consensus standards. Among those is IEC 60601-1-2, which covers basic safety and electromagnetic disturbances. Elite is fully equipped to perform testing per IEC 60601-1-2, which includes radiated and conducted immunity testing at levels depending on the equipment’s medical application.
For obvious reasons, the bar is high for medical equipment approval. The complexity and administrative challenge require a careful review of the applicable FDA requirements and a testing strategy specific to the device. Elite’s experience in these applications helps you navigate that process as your product moves into the exacting medical-device market. Contact Elite to find out what tests apply to your device and what steps are needed to begin the process toward FDA approval.