On June 06, 2022, the FDA issued a new EMC guidance (Electromagnetic Compatibility (EMC) of Medical Devices), replacing the 2016 version of the EMC guidance (Information to Support a Claim of Electromagnetic Compatibility (EMC) of Electrically-Powered Medical Devices).
Scope of Application:
This guidance applies to medical devices, including In vitro diagnostic (IVD), and accessories that are electrically powered or have functions or sensors that are implemented using electrical or electronic circuitry.
- In vitro diagnostic devices (IVD) : 1 year after the publication of this guideline, i.e., June 6, 2023.
- Other devices: 60 days after the publication of this guidance, i.e., August 5, 2022.
Main differences between the old and new EMC guidance：
Compared with the 2016 version of EMC Guide, this guide is more specific about the content requirements of EMC information you need to submit, and adds some new contents as follows.
1. Risk management assessment requirements.
A summary description of the risks associated with failure, disruption, or degradation of performance of the associated medical device due to electromagnetic interference is required.
2. Should consider the risk of interference from common electromagnetic emitters not adequately addressed by FDA-approved consensus standards.
Such as radio frequency identification (RFID) readers, electronic security systems (e.g., metal detectors, electronic article surveillance), near-field communication (NFC) systems, wireless power transmission (WPT), cellular 5G, and unique medical transmitters (e.g., electrocautery, MRI, electrosurgical devices, and fluoroscopy devices).
3. New IDE or IND submission requires reference to EMC information.
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