The new article describes in detail the aspects related to technical characteristics and the way they should be treated in the context of substantial equivalence under the 510(k) framework.
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 evaluation of substantial equivalence in premarket notifications [510(k)]. The document describes the approach to be applied by medical device manufacturers and other parties involved when the references to similar medical devices already placed on the market (predicates) are made to demonstrate compliance with the applicable regulatory requirements. The document provides additional clarifications on the related matters, as well as recommendations to be taken into consideration to ensure compliance with the requirements set forth by existing legislation. At the same time, guidance documents issued by the FDA are non-binding, so they are not intended to introduce new rules or impose new obligations. Moreover, an alternative approach could be applied, provided such an approach is in line with the respective regulations and has been agreed with the authority in advance.
Technological Characteristics: Key Points
Once a predicate device has been identified and provided both products have the same intended use, the authority will proceed with comparing technological characteristics to identify the differences and assess the impact these differences cause on the matters related to safety and effectiveness. In this respect, the authority mentions that it is a common situation when the products subject to review have different technological characteristics. At the same time, such a difference does not mean the products could not be considered substantially equivalent.
The document further describes in detail the particular steps the FDA will take when assessing the technological characteristics and their impact on the safety and performance of medical devices.
Identification of Technological Characteristics
In the first step, the authority will identify the technological characteristics of the devices based on the information provided by the medical device manufacturer claiming substantial equivalence. According to the guidance, the scope of technical characteristics to be assessed includes materials used, design of the product, its energy source, and other important aspects highlighted in the applicable legislation. In particular, it is stated that to facilitate the FDA`s review of a device’s technological characteristics, the device description in a 510(k) should include the information necessary to explain the new device’s technological characteristics, including similarities in materials, design, energy source, and the device features; this information will be evaluated by FDA to determine whether the technological characteristics of the new device are different and, if so, whether they raise different questions of safety and effectiveness as compared to the predicate(s).
As further explained by the FDA, the characteristics to be covered by the scope of information provided by the manufacturer include, inter alia, the following ones:
- Device design. An applicant entity is expected to describe the product in question, detailed enough for the FDA to be able to assess the matters related to the devices’ safety and effectiveness. Such a description could also contain necessary drawings or figures. Should the product subject to review be composed of several components, a detailed description of such components, as well as the way they interact and work with each other should be provided. It is also important to provide details about key physical specifications and dimensions. According to the guidance, significant features of the new device should have a clear purpose within the context of the overall design and intended use; in cases where this is not apparent, the 510(k) submission needs to provide a discussion of how a particular device design or component contributes to the overall use and function of the new device.
- Materials. The applicant is also expected to provide detailed information about all the materials the device is composed of. At the same time, the authority explicitly states that it cannot directly “approve” the use of specific materials. The information should also reflect any changes to the materials (e.d., color additives, coating, etc.) and processes that could impact the characteristics of the materials.
- Energy sources. The appropriate section should cover all the aspects related to energy that powers the device, as well as any other use of energy of any kind.
- Other key technological features. Apart from the aspects highlighted hereinabove, the scope of the submission should cover software/hardware features, density, porosity, degradation characteristics, nature of reagents (recombinant, plasma-derived, etc.), the principle of the assay method, etc., that are not explicitly included as part of the materials, design or energy source characteristics. These points should be duly addressed in the submission to ensure the authority has all the information necessary to assess the matters related to the safety and effectiveness of the device in question.
The authority also clarifies that apart from the information regarding the device itself, it is also necessary to provide the same details regarding the product indicated as a predicate. Such information should be detailed enough for the FDA to be able to compare the products and their characteristics.
Identification of Differences
At the next stage, the authority will identify the differences between products and assess the impact such differences have on safety and performance. For this purpose, the authority will compare the technological characteristics based on the information provided by the applicant. The authority also encourages medical device manufacturers to provide a summary table containing such a comparison to facilitate the review process.
Once the differences have been identified, the authority will take further steps to determine whether the differences in technological characteristics raise different questions of safety and effectiveness. The latter concept states for a question raised by the technological characteristics of the new device that did not apply to the predicate device and poses a significant safety or effectiveness concern for the new device. The guidance provides several examples of the way this approach should be applied. In particular, the decision should be made as follows:
- If the answer is “No”, meaning that the difference between the products does not create grounds for concerns related to the safety and performance, the authority will proceed with further review;
- If the answer is “Yes”, the products would be determined as non-substantially equivalent. However, in such a case, an interested party may still proceed with applying another framework (e.g., PMA), or De Novo’s request, if the product in question is based on innovative technologies.
In summary, the present FDA guidance describes the approach to be applied about the technological characteristics of medical devices and the way they should be reflected in documentation to be submitted by the applicant. The document highlights the most important aspects to be addressed in the documentation and outlines the main steps the whole regulatory process is composed of.
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