The new article describes in detail the aspects related to comparison to similar medical devices already placed on the market and also outlines the scope of information to be provided with respect to the software used to operate such devices.
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 the submissions under 510(k) premarket notification framework related to ultrasonic diathermy devices. The document describes in detail the scope of information the authority expects to be included in such applications, as well as certain specific matters.
It is also important to mention that FDA guidance documents are non-binding in their legal nature, nor are intended to introduce new rules or impose new obligations, but rather to provide additional clarifications regarding the applicable regulatory requirements, as well as recommendations to be considered by medical device manufacturers and other parties involved in order to ensure compliance thereto. Moreover, the authority explicitly states that an alternative approach could be applied, provided such an approach is in line with the existing legislation and has been agreed with the authority in advance.
The scope of the guidance covers, inter alia, the aspects related to comparison to a similar device placed on the market – predicate.
Under the general rule, for devices reviewed under the 510(k) process, manufacturers must compare their new device to a similar legally marketed predicate device to support its substantial equivalence (section 513(i) of the FD&C Act; 21 CFR 807.87(f)); this comparison should provide information to show how [the] device is similar to and different from the predicted; side by side comparisons, whenever possible, is desirable.
The guidance also provides examples illustrating how the information addressed in a comparison could be structured. Furthermore, the authority also mentions that the scope of comparison should also cover accessories intended to be used with a medical device in question, including their identification and comparison.
According to the guidance, the aforementioned comparison should be comprised of the following sections:
- Description of a medical device subject to review;
- Maximum values of powers and intensities;
- Information for amplitude modulated waves;
- Temperature specifications.
Software and Cybersecurity
Another important aspect addressed in the guidance relates to the software to be used for ultrasonic diathermy devices in order to ensure the energy delivered by the device meets the requirements set forth by the respective specification. Moreover, it is also important to conduct a proper testing in order to ensure the device operates as initially intended by its manufacturer and its performance is within the pre-defined parameters.
With respect to software-specific matters, the document refers to the respective guidance document dedicated to the context of premarket submissions for the software contained in medical devices. The said guidance outlines the scope of documentation the authority expects to be submitted with respect to the software operating a medical device. As described in that guidance, the level of the applicable regulatory scrutiny will depend on the respective “level of concern” associated with the product in question. Under the general rule, software used for ultrasonic diathermy medical devices addressed in the guidance constitutes a “Major” level of concern.
For certain specific aspects, the document also refers to the FDA guidance document dedicated to the general principles of the software validation.
Apart from the above, the authority also encourages the parties responsible for medical devices to submit a complete description of the software/firmware supporting the operations of the device in question as prescribed by the respective guidance document. The authority additionally emphasises that the said approach should be applied with respect to both medical devices initially placed on the market, as well as the ones undergoing modifications to the software or firmware while being allowed for marketing and use in the US. With respect to the latter, the authority additionally emphasizes that in accordance with the existing regulatory requirements, changes to the software operating an ultrasonic diathermy medical device should be subject to revalidation and revivification. Moreover, some of the changes could even trigger an obligation to submit an entirely new application under the 510(k) premarket notification framework. With respect to the latter point, the authority refers to the respective guidance work on deciding when to submit a 510(k) for a software change to an existing device. Furthermore, the applicants are also expected to provide information on cybersecurity-related matters – the ones addressed in the FDA guidance on the content of premarket submissions for the management of cybersecurity in medical devices.
Should it appear that the device subject to review includes an off-the-shelf software, the appropriate information should be provided as well.
In summary, the authority states that the documentation related to the software contained in the medical device should, among other things, provide sufficient evidence to describe the role of the software included in the device, and performance testing to demonstrate that the software functions as designed.
Thus, the present FDA guidance provides an overview of the applicable regulatory requirements for 510(k) premarket notification submissions associated with ultrasonic diathermy devices in the context of predicate comparison. The document also describes in the detail the aspects to be addressed in the application for marketing approval under the 510(k) framework with respect to the software used to operate a medical device and cybersecurity.
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