Additional Immunity Tests for FDA 510K Approval
Electromagnetic compatibility (EMC) testing is required by the FDA for nearly all medical devices. EMC is defined as the ability of a device to function safely and effectively in its intended electromagnetic environment. This includes immunity to electromagnetic disturbance (interference), without introducing excessive electromagnetic disturbances or emissions that might interfere with other devices.
AIM 7351731 specifically applies to medical electrical equipment and systems to make sure that RFID Readers in the area do not affect the device’s operation. In addition to AIM 7351731, the FDA almost always also requires testing to ensure other types of devices won’t interfere with a product’s function. Here are some examples of known-disturbances the FDA requires products to be evaluated with:
- Metal Detectors
- Electronic Article Surveillance (EAS)
- X-ray devices.
The FDA has developed a document to describe relevant information that should be provided in a premarket submission to support a claim of electromagnetic compatibility (EMC) for an electrically-powered medical device. In this document and relevant standards, the FDA outlines what degree of detail about your product they require for a premarket submission. This submission should include:
- the environment as defined by the manufacturer;
- a summary of testing performed;
- what specifications of each standard were met;
- functions of the device tested;
- details of the performance of the device;
- identification and justification for any deviation from specifications of standards met;
- device labeling;
- description of all changes and modifications made to the device post-testing;
- and more.
This being said, the FDA is also free to request additional information depending on the use and intended use environment of a specific active medical device to demonstrate EMC. This request typically comes from the FDA reviewer who sends feedback to manufacturers and says something akin to the statement below:
|“IEC 60601-1-2 standard generally does not adequately address EMC for several common RF emitters. Please specifically address exposure to known sources of EMI with medical devices such as diathermy, electrosurgical, X-ray, RFID, security systems (e.g. anti-theft systems, metal detectors). Please note some of these RF emitters (e.g. RFID) may not be visible and the device can potentially be exposed to fields from these RF emitters without the user’s awareness.”|
F2 Labs is prepared to help you determine and define all of these requirements for FDA approval in order to make your testing experience as smooth as possible. Contact us today for more information.