The Food and Drug Administration (FDA) has published guidance addressing the most important aspects related to the use of radio frequency wireless technology in medical devices. The document does not establish legally binding obligations but only describes the current thinking of the FDA regarding the matter and also provides certain recommendations to be considered by the medical device manufacturers and other parties involved.
Regulatory Background
As it was already mentioned before, the present FDA guidance is dedicated to the issues related to the integration of radio frequency wireless technology in medical devices which takes place more and more often nowadays. Thus, all RF-related matters should be considered carefully in the context of the safety and performance of medical devices. In particular, the FDA guidance on radio frequency (RF) wireless technology in medical devices describes the most important considerations, including electromagnetic compatibility (EMC). The scope of this guidance covers such aspects as:
- Selection of wireless technology,
- Quality of service,
- Coexistence,
- Security,
- Electromagnetic compatibility.
The aforementioned points should be taken into consideration for all medical devices employing radio frequency wireless technology.
The Agency also mentions that the radio frequency wireless technologies should be used in accordance with the appropriate certification or license to be granted by the Federal Communications Commission (FCC) – the US regulating authority in this sphere.
The document also outlines the scope of the information to be submitted by the interested parties when applying for the premarket approval for medical devices based on the use of RF wireless technology. However, the present guidance covers only the requirements subject to the jurisdiction of the FDA, while the requirements related to other agencies are actually falling outside the scope of the present guidance.
The scope of the guidance covers all types of medical devices including both external and implantable, irrespectively of the environment the device is initially intended to be used in. The Agency additionally emphasizes the following:
- The scope of the guidance also covers radiated radio frequency technology devices, as well as induction-based ones, while
- The devices using the radio frequency energy to create an image of the internal structure of a human body are actually falling outside the scope of the present guidance.
Considerations for Design, Testing, and Use of Wireless Medical Devices
The FDA places an emphasis on important considering the intended performance of the device in the context of other radio frequency wireless technology devices that could be also present in the intended use environment. Consequently, the medical device manufacturer shall develop and implement the measures necessary to ensure the correct operations of medical devices under the aforementioned conditions, including such aspect as correct, timely, and secure transmission of critical data which is necessary to ensure the use of the device in a safe and efficient manner within the whole expected lifecycle of the product. This aspect becomes vitally important in case if it is related to life-supporting or life-sustaining functions.
In order to assist medical device manufacturers, the Agency also outlines the most common risks associated with medical devices based on radio frequency wireless technology, namely:
- Malfunctions related to the wireless systems,
- Errors related to data transmission, including delays or losses of data caused by the impact of electromagnetic interference (EMI),
- Insufficient wireless security measures,
- Certain misuse cases could take place due to the unclear instructions for use accompanying the device.
The Agency refers to the international standard ISO 14971 Second edition 2007-03-01 Medical devices – Application of risk management to medical devices in the context of the approach to risk analysis and risk management.
It is also important to mention that the Agency recommends considering carefully on a case-by-case basis whether the particular function should be based on a wireless solution, or could use a wired connection since the latter is much more reliable and secure. Thus, each time adding new functions based on a wireless technology, the medical device manufacturer shall conduct a rigorous analysis and assess all benefits and detriments of using wireless technology with regard to the performance of a medical device and the safety of its potential users (patients).
According to the document, all known safety-related issues associated with the use of radio frequency wireless technology should be addressed at the very beginning of the development process. All identified risks should be assessed from the perspective of acceptable risk – in particular, they should not exceed the acceptable level of the overall risk. The risk acceptability criteria to be applied by the medical device manufacturer should be based on the intended use of the medical device, and also the industry best practices and applicable standards.
Radio Frequency Wireless Technology Devices: Information to be Submitted
As it was already mentioned before, the Agency also provides certain recommendations regarding the information to be included in the application for the premarket approval. For instance, the FDA recommends providing risk analysis of radio frequency wireless communications. Moreover, the risk assessment should also cover such aspects as the potential impact of the electromagnetic disturbance (EMD).
The medical device manufacturer shall also consider the possible adverse events and their potential consequences.
In the terms of the information to be submitted, the Agency provides the following recommendations:
- Description of the device should include the details about the wireless technology and functions, as well as the intended use of the device and the environment it is intended to be used in. The manufacturer shall also describe the technical measures and controls implemented to ensure the safe and effective use of the device. This section should also cover the aspects related to the connections with other devices.
- A risk-based approach to verification and validation. The manufacturer is expected to provide the information about Wireless Quality of Service (QoS), including all known potential data-related risks; wireless coexistence, and also the risks associated with the security of wireless signals and data to be transmitted by the means of wireless technologies. This section should also contain information about electromagnetic compatibility.
- Test data summaries. The manufacturer shall provide detailed information about the tests performed, any deviations from applicable standards, and also to indicate the specific model of the medical device subject to testing, as well as the applicable pass/fail criteria. The authority also mentions that in case if certain modifications have been implemented as necessary to pass testing, the manufacturer shall also provide a statement confirming that the same modifications would be implemented for all medical devices of the same model.
- Labeling. The aspects related to the labeling of medical devices based on radio frequency wireless technology are especially important since the manufacturer shall provide healthcare professionals or laypersons using the device with all information necessary to ensure the use of the device in a safe and efficient manner.
Summarizing the information provided here above, the present FDA guidance addresses the most important considerations for medical devices utilizing radio frequency wireless technology. The document also contains certain recommendations regarding the scope of information to be provided by the medical device manufacturer when applying for the premarket approval, including the references to the applicable standards and regulations.
How Can RegDesk Help?
RegDesk is a next-generation web-based software for medical device and IVD companies. Our cutting-edge platform uses machine learning to provide regulatory intelligence, application preparation, submission, and approvals management globally. Our clients also have access to our network of over 4000 compliance experts worldwide to obtain verification on critical questions. Applications that normally take 6 months to prepare can now be prepared within 6 days using RegDesk Dash(TM). Global expansion has never been this simple.
Sources:
