The new article describes in detail the aspects related to the intended use of medical devices and the ways it should be considered when evaluating substantial equivalence.
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 the context of the 510(k) framework. Under the general rule, medical device manufacturers may demonstrate substantial equivalence of their products to similar devices already placed on the market to confirm compliance with the applicable regulatory requirements. Such an approach allows to substantially reduce the unneeded regulatory burden and accelerate the process of placing new medical devices on the market. The guidance is intended to provide clarifications regarding the way the interested parties should interpret and follow the provisions of the applicable legislation, as well as additional recommendations to be considered by medical device manufacturers and other parties involved to ensure compliance thereto. At the same time, the document itself is non-binding in its legal nature, nor is intended to introduce new rules or impose new requirements. Moreover, the authority also mentions that an alternative approach could be applied, provided such an approach complies with the respective regulatory requirements and has been agreed with the authority in advance.
Intended Use: Key Principles
Under the general rule, FDA may only determine that a device is substantially equivalent to a predicate device if it has the same intended use. Should the intended use be different, the authority could make a decision stating that the products could not be considered substantially equivalent. The said approach is based on the principle according to which a change in the intended use results in a new intended use created. As further explained by the FDA, for substantial equivalence, the term intended use means the general purpose of the device or its function, and encompasses the indications for use; while the latter is used to describe a specific condition for which the product is intended to be used. The scope of the indications for use also covers the intended patient population. The intended use should be taken into consideration when determining the admissibility of the device for placing on the market under the 510(k) framework since in certain cases other pathways should be followed – for example, PMA or De Novo (a special framework for novel medical devices based on innovative technologies and having no similar devices already placed on the market). The assessment of the intended use will be based on the information communicated by the medical device manufacturer by the virtue of the product’s labeling. In this respect, the authority additionally emphasizes the importance of consistency of all the statements and claims made by the manufacturer concerning the product, its functions, and features.
For the substantial equivalence to be established, the indications for use of a medical device in question should meet the ones for the product that is already placed on the market (predicate). In case there is no indication of a specific condition, the indications for use and intended use should be the same. The authority describes such situations by referring to the “tool type” indications for use, which applies to all products for which the particular indications for use are not specified.
Determining Intended Use
As was mentioned before, when assessing the intended use, the authority will consider the information contained in the labeling of the device subject to review. Should the authority identify that the information regarding the intended use provided in the documentation accompanying the device is the same as for the device the manufacturer refers to when claiming the substantial equivalence, it would be possible to determine that both products have the same intended use. It is important to mention that certain aspects associated with the assessment of the intended use in specific cases are not covered by the scope of the present guidance, but are addressed in the appropriate documents issued by the FDA. Should it be identified that the indications for use are different, the authority would further assess whether these indications are covered by the same intended use. According to the guidance, because the substantial equivalence determination is grounded in safety and effectiveness, this determination depends upon the safety and effectiveness of the new device for the new indications relative to the safety and effectiveness of the predicate device. Should the authority identify the indications for use based on documentation provided by the manufacturer, it will further be able to assess additional information related to the device, including the data deriving from clinical or scientific assessments of similar products to evaluate the safety and effectiveness of the device in question.
New Intended Use
The document also describes the cases when a new intended use should be determined due to the changes to the indications for use impacting the safety or performance of the product. In this respect, the authority states that only a change in the indications for use that raises different questions of safety and effectiveness and therefore, precludes a meaningful comparison with the predicate device constitutes a new intended use. For instance, this could take place in case the changes to the indications for use result in additional risks that were not assessed for the predicate, or in case such changes could significantly increase the known risks associated with the device. In both aforementioned cases, a comparison of the devices in terms of risks would not be reliable enough. The guidance also provides several examples demonstrating the cases described hereinabove.
Apart from this, the FDA also outlines the scope of changes that could potentially result in a new intended use, so should be considered carefully during the assessment. This includes, inter alia, the following changes:
- A change from a functional/performance indication to a treatment or aesthetic indication;
- A change from a diagnostic indication to a screening indication, or vice versa;
- A change in the anatomical structure of use;
- A change in the patient population (e.g., adult versus pediatric; different disease populations);
- A change in the clinical context or setting (e.g., periodic monitoring versus continuous monitoring; hospital versus home use).
In summary, the present FDA guidance describes the way the aspects related to the intended use and indications for use should be considered when establishing a substantial equivalence in the context of the 510(k) pathway. The document highlights the main points and also outlines specific cases when additional attention should be paid.
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