The new article highlights the key points related to comparator devices in the context of submitting clinical evidence when applying for marketing approval.
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Health Canada, a country’s regulatory agency in the sphere of healthcare products, has published a guidance document dedicated to clinical evidence. The document provides an overview of the applicable regulatory requirements, as well as additional recommendations to be considered by medical device manufacturers and other parties involved in order to ensure complaint thereto. At the same time, provisions of the guidance are non-binding in their nature, nor are intended to introduce new rules or impose new obligations. The authority also reserves the right to make changes thereto, should such changes be reasonably necessary to reflect corresponding amendments to the underlying regulations.
The scope of the guidance covers, inter alia, the aspects related to comparator devices.
Regulatory Background
Under the general rule, for some of the devices intended to be marketed in Canada, device-specific clinical data is required in order to demonstrate compliance with the applicable regulatory requirements such devices are subject to. At the same time, the authority acknowledges that medical devices could be subject to changes and modifications. Sometimes, these changes are not significant, so the clinical data related to the initial device could be used. As further explained by Health Canada, where pre-clinical bench testing and side-by-side comparisons can objectively demonstrate that the clinical performance of 2 devices is equivalent, then there is less likely a need for device-specific clinical data. It is also stated that the initial device used as a comparator has been, in most cases, already assessed by the authority with respect to its safety and effectiveness. Medical device manufacturers may rely on this fact when justifying that device-specific clinical data is not needed.
Should appear that there is no medical device that could be used as a comparator, a party responsible for a medical device may also use data from the sources that are publicly available in order to assess the performance of a new medical device, so the device-specific clinical data won’t be required. For this purpose, a party responsible for a device in question should:
- Provide a detailed side-by-side comparison of the subject device with the unlicensed comparator; and
- Demonstrate sufficient similarity in order to make use of the published data.
The authority additionally emphasizes the importance of ensuring that the device-specific clinical data is available for a comparator. It is also stated that the authority will either accept or refuse to accept the comparator data referred to as separate evidence of compliance with the applicable regulatory requirements. According to the guidance, the authority’s decision will depend on how solid and applicable the clinical data suggested by the applicant is, and will also take into consideration any uncertainties and differences present.
When making references to a comparator, medical device manufacturers should provide the authority with a comprehensive comparison of the products. As it is stated in the guidance, in order to demonstrate equivalence, the scope of comparison should cover such aspects as:
- Design,
- Materials,
- Specifications,
- Indications for use,
- Physical properties,
- Diagnostic algorithms,
- Chemical formulations,
- Performance capabilities, and
- Any other equivalent or relevant features.
According to the guidance, when referring to a comparator, medical device manufacturers will have to demonstrate that the information available provides a clear understating of the clinical performance of the device in question. It is further stated that the need for additional device-specific clinical investigation will depend on the extent to which the clinical evidence available covers the aspects related to the safety and effectiveness of the device, as well as the risks associated thereto.
It is also important to mention that some types of medical devices will anyway require device-specific data to be submitted.
Selecting a Device for Comparison
The guidance also highlights the key matters to be considered when selecting a medical device to be used as a comparator. In this respect, the authority explicitly states that medical device manufacturers should not compare the products that:
- Do not have the same intended uses;
- Do not have objective evidence for safety and effectiveness;
- Cannot be demonstrated to be technically similar to the subject device.
Furthermore, it is stated that the device selected to be used as a comparator should be the one that is usually used in such cases. The applicant will have to provide information demonstrating that the device chosen operates as intended, while the risks associated thereto are identified and managed. The evidence provided should rely on best practices and be relevant at the moment of submission. According to the guidance, it will be also useful to submit post-market performance data available in order to demonstrate the way the device operates when used for its intended purpose.
Criteria for Comparing Medical Devices
Apart from the general information about comparisons and the way a comparator should be chosen, the document also outlines specific criteria to be used when comparing medical devices in order to assess their actual safety and effectiveness. First of all, a medical device manufacturer intending to use the data related to a different device should ensure it was used in similar conditions for the same purpose, so the data is relevant to the device in question.
In general, the scope of comparison should cover the following key aspects:
- Indications for use and/or intended use;
- Technological characteristics; and
- Performance of the device (or biological safety if applicable).
In summary, the present guidance issued by Health Canada describes in detail the approach to be applied when using clinical evidence related to a medical device already placed on the market to substantiate the claims for a new medical device subject to review. The document highlights the key points to be considered when choosing a medical device to be used as a comparator, and also outlines the specific criteria to be applied.
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