The new article addresses the aspects related to the application of wireless technologies that are widely used in medical devices nowadays, as well as to certain safety-related matters.
The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has published a guidance document dedicated to photobiomodulation (PBM) devices in the context of premarket notification submissions under the 510(k) framework. The document provides additional clarifications regarding the applicable regulatory requirements, as well as recommendations to be taken into consideration by medical device manufacturers and other parties involved in order to ensure compliance thereto. At the same time, provisions of the guidance are non-binding in their legal nature, nor are intended to introduce new rules or impose new obligations. Moreover, the authority explicitly states that an alternative approach could be applied, provided such an approach is in line with the respective legislation and has been agreed with the authority in advance. 

The scope of the guidance covers, inter alia, the aspects related to the use of wireless technologies, thermal safety, and eye safety. Each of the above factors is described in detail, and the appropriate recommendations are provided.

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Wireless Technology 

As explained by the FDA, the matters related to the use of wireless technologies are important since in the design, testing, and use of wireless medical devices, the correct, timely, and secure transmission of medical data and information is essential for the safe and effective use of both wired and wireless medical devices and systems. In order to make sure the above matters are properly addressed, the authority recommends medical device manufacturers to conduct testing as prescribed by the IEC 60601 standards with respect to any and all PBM devices utilizing wireless technologies. For the purpose of this guidance, wireless technologies include, inter alia, Bluetooth, IEEE 802.11 (WiFi), or radio frequency identification (RFID) technologies. The testing to be conducted should demonstrate that the wireless function the device in question contains operates as intended when used in the intended use environment (this becomes especially important since other devices using wireless technologies could be present in the use environment so it is important to make sure there are no cross-interference in their operations). For additional details, the authority refers to separate guidance documents, namely “Design Considerations for Devices Intended for Home Use”, and “Radio Frequency Wireless Technology in Medical Devices” addressing specific aspects related to the matters highlighted above. 


Thermal Safety 

Another important aspect addressed in the guidance is thermal safety. Under the general rule, PBM devices are not usually supposed to raise skin or body temperature when used for the intended purpose. At the same time, the authority acknowledges that it is possible for some PBM devices with relatively higher irradiances or devices that cover certain parts of the body (e.g., masks and helmets) to increase the tissue temperature to dangerous levels if used for long periods of time and/or in close contact. 

According to the guidance, should it be identified that the PBM device in question could increase the tissue temperature when being used as intended by the manufacturer, the risks associated thereto should be duly mitigated. In particular, medical device manufacturers are expected to demonstrate that the device, when operating properly, will not cause any tissue damage. For this purpose, skin temperature measurements could be provided. The authority also mentions that in situations when the device is known to create risks of tissue damage when overused, manufacturers are encouraged to integrate time limits. Depending on the device and its specific features, the said limits could be implemented on the software or hardware levels. Apart from that, tissue temperature sensors could be used to perform continuous monitoring and ensure timely detection of any temperature rise that could be potentially harmful, resulting in the device being shut off to prevent harm caused to the patient. According to the document, the above becomes vitally important in the case of over-the-counter devices.

Eye Safety 

Apart from the questions described hereabove, the scope of the guidance also covers the aspects related to eye safety. In this respect, the authority states that PBM devices pose a risk for ocular tissue damage as they may deliver energy and irradiance values greater than the maximum permissible exposure for the patient’s or user’s eyes. In order to ensure eye safety, the use of special eyewear could be required, while detailed information about such measures should be duly included in the instructions for use and other documentation accompanying the device so that potential users will be aware of all the safety measures to be taken when using the device for its intended purpose. Furthermore, medical device manufacturers are encouraged to measure the energy and irradiance output values of [their] device to determine which safety measures, if any, would be appropriate. Apart from that, the authority additionally emphasizes that for cold sore devices, the scope of performance testing conducted should cover, inter alia, the validation of ocular safety. 

In summary, the present FDA guidance provides an overview of the regulatory requirements associated with certain safety-related matters – the use of wireless technologies, as well as thermal and eye safety. The document highlights the key points to be taken into consideration by medical device manufacturers in order to ensure compliance with the said requirements, as well as the overall safety of the products they are responsible for and general public health protection.  



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