The FDA wants manufacturers of low-energy ultrasound wound cleaners to provide evidence that their devices will not interfere with the performance of other medical devices, according to a recently released final guidance.
The agency believes that special controls, when combined with general controls, will be sufficient to provide reasonable assurance of the safety and effectiveness of the low-energy ultrasound wound cleaner. The FDA added that the final guidance would serve as a special control guidance to support classifying such products as Class II devices. Special controls are specific regulatory requirements meant to ensure a product's safety and effectiveness.
Manufacturers should assess the product's electromagnetic compatibility to show the device will not negatively interfere with the performance of other electronic devices, such as pacemakers and defibrillators, the FDA said. The testing should also include radio frequency electromagnetic, low-frequency magnetic and conducted emissions, the guidance added.
The agency also recommended that manufacturers provide the FDA with the device's acoustic characteristics, including the level of ultrasound energy transmitted to the patient and the level of airborne ultrasound energy generated by the product. The guidance, "Class II Special Controls Guidance Document: Low Energy Ultrasound Wound Cleaner," is online at http://www.fda.gov/OHRMS/DOCKETS/98fr/05g-0367-gdl0001.pdf (http://www.fda.gov/OHRMS/DOCKETS/98fr/05g-0367-gdl0001.pdf).
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