The new article highlights the key points related to the regulatory evidence for cardiovascular devices.
The Therapeutic Goods Administration (TGA), an Australian regulatory agency in the sphere of healthcare products, has published a guidance document dedicated to the clinical evidence of medical devices. The document provides an overview of the applicable regulatory requirements, as well as recommendations to be considered by medical device manufacturers and other parties involved to ensure compliance thereto. In particular, the guidance describes in detail the requirements to be applied for various types of medical devices depending on their specific features and risks associated thereto. At the same time, provisions of the guidance are non-binding, nor are intended to introduce new rules or impose new obligations the parties involved should follow. The authority also mentions that the recommendations provided in the guidance could be subject to changes, should such changes be reasonably necessary to reflect corresponding amendments to the underlying regulations.
The present article describes the regulatory policy to be applied for clinical evidence for cardiovascular devices used to promote patency or functional flow (also referred to as “CV flow implants”). As it is stated by the TGA, the document outlines the minimum levels of evidence in the context of safety- and performance-related matters, as well as the minimum clinical outcomes that define clinical success and demonstrate that a CV flow implant performs as intended.
First of all, the document provides a summary of the most important recommendations to be taken into consideration for clinical evidence for CV flow implants. According to the guidance, the said recommendations could be applied for arterial stents-carotid, coronary and peripheral, implants for abdominal aortic aneurysms repair, implants for patent ductus arterioles (PDA) repair, and inferior vena cava (IVC) filters to prevent pulmonary embolism (PE). The authority mentions that such devices are complex products intended to be used either separately or together with other devices. In the latter case, the scope of evidence the authority expects to receive should also address the matters related to combinations and configurations possible.
When applying such a medical device, a responsible party would have to demonstrate that the product in question:
- Is in established substantial equivalence to a similar device already placed on the market; and
- Any differences in comparison to a similar device (comparable product) would not adversely affect the safety and effectiveness of the device subject to review.
Furthermore, the authority expects medical device manufacturers to provide details regarding the way clinical data used as a basis for clinical evidence has been collected. In particular, it is important to provide detailed enough information about study subjects (patients) demonstrating the approach applied concerning patient selection.
According to the guidance, manufacturers who intend to conduct clinical trials should design trials to the highest practical NHMRC Level of Evidence; trials should be appropriate to inform on the safety and performance of the device for its intended purpose.
For the way clinical data should be provided, the authority mentions the following:
- The main clinical outcomes necessary to assess the safety and effectiveness of a medical device would depend on its type. In particular, it is advised that a clinical justification is provided to support the selection of the primary outcomes and if necessary the use of secondary outcomes or surrogate markets. When making such an assessment, the manufacturer should use respective data for similar products as a reference point. Moreover, the authority encourages medical device manufacturers to submit post-market data demonstrating continuous compliance with the safety- and performance-related requirements in the long-term perspective. Manufacturers may also rely on a literature review, in such a case, it will be necessary to provide the details regarding the particular method used to perform the search for the authority to be able to ensure the accuracy and reliability of the results.
- The TGA additionally emphasizes the importance of ensuring that all the risks identified in the course of clinical data assessment are duly mitigated or reflected in the instructions for use and other documentation accompanying the device.
AOANJRR Annual Report
According to the guidance, the AOANJRR Annual Report constitutes one of the most important sources of post-market data the authority is going to use in the course of surveillance activities for joint prostheses. The AOANJRR stands for the Australian Orthopedic Association National Joint Replacement Registry, which is an organization funded by the government, its primary activity is the collection of data related to joint replacement and revision procedures carried out in the country. For instance, according to the guidance, the AOANJRR has collected data on 98 to 100% of hip and knee joint replacement procedures performed in Australia since 2003; the information that is collected for the primary joint replacement procedure includes, but is not limited to, de-identified baseline patient demographics, the name and brand of the device implanted, method of prosthesis fixation, surgical technique, the indication for the joint replacement and the date and location of the procedure. The authority also mentions that in case of a revision, a similar set of information is to be collected.
As further explained by the TGA, when collecting and analyzing the data related to joint prostheses replacement and revision procedures, the AOANJRR is using statistical methods to be able to identify an estimate of the revision rate for each specific product. This information makes it possible to compare different products and the way they operate in time. At the moment, the revision rate is used as a key performance and safety indicator for medical devices of this type. To assist all the parties involved, the AOANJRR publishes reports on an annual basis, sharing the information collected. In particular, such reports contain details about revision rates for joint prostheses used, as well as about the reasons for the revision. Apart from this, the said annual reports identify the products as having a “Higher Than Anticipated Revision Rate”.
The information prepared by the AOANJRR is widely used by TGA, the country’s regulating authority, together with the data deriving from other sources – for instance, from post-market surveillance activities undertaken by all the parties involved in operations with medical devices, or literature review. This information and data are used by the authority to monitor the actual safety and performance of the products covered by the scope of the present guidance. It is also important to mention that apart from the information published by the AOANJRR in their Annual Reports, the authority is also entitled to request the organization to provide additional analysis concerning a specific device.
Actions to be Taken
As it was mentioned before, post-market surveillance activities are undertaken to ensure the identification of the safety-related issues associated with joint prostheses promptly, and also to ensure that all the actions reasonably necessary to ensure the public health protection and safety of patients are duly taken when necessary. For instance, in the course of post-market surveillance, it could be identified that additional intervention is required to mitigate the risks associated with a specific device. These additional actions could be initiated by a party responsible for a medical device itself, or by the authority. According to the guidance, such actions include, inter alia, the following ones:
- Cancellation from the ARTG,
- A product recall,
- Product Defect Correction,
- Hazard Alert.
Additional information regarding the above mentioned actions and the way they should be undertaken is provided on separate pages of the official website.
In summary, the present TGA guidance provides an overview of the approach to be applied concerning post-market surveillance activities in the context of joint prostheses. The document describes the main sources of data to be taken into consideration and also outlines the actions to be taken in case safety-related issues are identified.
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