The new article addresses the matters related to labeling requirements the devices should comply with in order to be allowed for marketing and use in the country.
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 submission related to ultrasonic diathermy devices under the 510(k) premarket notification framework. The document provides an overview of the applicable regulatory requirements, as well as recommendations and additional clarifications 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 existing regulatory framework and has been agreed with the authority in advance.
The scope of the guidance covers, inter alia, the aspects related to labeling for ultrasonic diathermy devices. In particular, the document outlines the scope of information to be included in premarket submissions.
Labeling: Key Points
Under the general rule, a submission under 510(k) premarket notification framework should include detailed enough information about the labeling to be used for the medical device in question, sufficient for the authority to establish compliance with the applicable regulatory requirements set forth by regulation 21 CFR 807.87(e). In accordance with the said requirements, the labeling should contain a description of the device itself, and also the details on its intended use and the appropriate instructions for use communicating important use-related information to the customers.
The authority also mentions that as prescription devices, ultrasonic diathermy devices are exempt from having adequate instructions for use under section 502(f)(1) of the FD&C Act, as long as the conditions in 21 CFR 801.109 are met; for instance, the labeling must include adequate information for practitioner use of the device, including indications, effects, routes, methods, frequency, and duration of administration, as well as any relevant hazards, contraindications, side effects, and precautions (21 CFR 801.109(d)).
As further explained by the FDA, apart from the basic elements outlined hereabove, the labeling should also include the following information:
- Additional label/tag to be placed on the generator housing, containing the details of the manufacturer, indication of manufacturing date, brand name, as well as information on the main technical characteristics (including the acoustic working frequencies, the type of waveform, etc.);
- General technical characteristics, including but not limited to the rated output power in watts, the effective radiating area in square centimeters, the beam non-uniformity ratio, and the beam type;
- Details about each and every operation control, including the units of measure (if a separate control and indicator are associated with the same function, then the labeling for the indicator should include the appropriate units of measure of that function);
- Each service control that is accessible without displacement or removal of any part of the ultrasonic diathermy device should be clearly labeled, identifying the function controlled, and include the phrase “for service adjustment only”.
The document also describes in detail specific aspects to be addressed in the labeling used for ultrasonic diathermy devices. One of the most important aspects relates to contraindications to be communicated to potential customers in order to ensure the safety of patients. The information to be provided in this section should be based on the risks already known to the manufacturer. The document contains a list of samples to be used, however, should the manufacturer determine that some of these indications are not applicable, the appropriate justification should be provided.
The list of samples provided in the guidance includes, inter alia, the following ones:
- Patients with an implanted medical device other than a pacemaker such as implanted deep brain stimulation device.
- Over or near bone growth centers until bone growth is complete.
- Over the thoracic area if the patient is using a cardiac pacemaker.
- Over a healing fracture.
- Over the eye.
Apart from the contraindications outlined hereabove, the labeling used for ultrasonic diathermy devices should also include the appropriate warnings to be duly communicated to potential customers. According to the guidance, such warnings could be:
- The treatment head should be moved continuously during treatment to avoid discomfort and burns.
- An appropriate coupling medium should be used in order to ensure energy transmission to the tissue.
According to the guidance, the labeling should also describe specific precautions to be taken into consideration when the device is used for its intended purpose in order to ensure its safety and proper performance. Information about precautions should be also included in the labeling used for ultrasonic diathermy devices. Such precautions could, for instance, indicate the limitations related to specific areas of use or categories of patients. For example, precautions could notify about the risks associated with the use of these devices in the following cases:
- Over anesthetized areas,
- On patients with hemorrhagic diatheses,
- Over areas where there is sensory impairment or sensory loss,
- Over the anterior aspect of the neck.
In summary, the present FDA guidance describes in detail the aspects to be considered with respect to labeling requirements for ultrasonic diathermy devices. The document outlines the scope of information to be included in labeling in order to ensure the proper use of the device and its continuous safety.
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