The new article describes in detail specific aspects related to the regulatory requirements for clinical evidence for cardiovascular devices.
The Therapeutic Goods Administration (TGA), an Australian regulating authority in the sphere of healthcare products, has published a guidance document dedicated to clinical evidence for various types of medical devices. In particular, the document provides additional clarifications regarding the regulatory requirements to be applied depending on the nature of the device, its specific features, and the risks associated thereto. It is also important to mention that the present document is not intended to introduce additional rules or impose new obligations, but rather to provide recommendations to be considered by medical device manufacturers and other parties involved to ensure compliance thereto. The authority also reserves the right to make changes to the guidance, should such changes be reasonably necessary to reflect the corresponding amendments to the underlying legislation. The scope of the guidance covers, inter alia, the aspects related to the clinical evidence for cardiovascular devices.
Under the general rule, the clinical evidence can be derived from clinical investigation(s) data, a comprehensive literature review, and/or clinical experience (generally post-market data) from the use of the device and/or comparable device. It is also stated that the intended purpose, clinical indications, claims, and contraindications must be supported by the clinical data. The authority additionally emphasizes that in case of changes made to a medical device after the initial clinical data has been collected, such changes should be duly documented, and the version of the device should be indicated. According to the document, direct evidence should be used whenever possible, however, indirect clinical evidence could be used provided substantial equivalence has been demonstrated by the virtue of providing a comparison to a similar medical device already placed on the market (predicate) in terms of clinical, technical, and biological characteristics. In this respect, the authority refers to the separate guidance document dedicated to comparable devices including substantially equivalent devices. In case both the medical device in question and the predicate have a common design, a party responsible for a medical device should provide a list of all devices based on the same design.
According to the guidance, the design of the clinical investigation should be appropriate to generate valid measures of clinical performance and safety. The authority encourages the parties responsible for clinical studies (sponsors) to develop the study design based on the clinical practice in Australia. The aspects to be taken into consideration should also include the characteristics of a medical device in question, as well as its intended purpose. Apart from this, it is also important to take into account clinical data deriving from comparable devices. A study sponsor should clearly outline the exclusion/inclusion criteria to be used for patient selection. Furthermore, medical device manufacturers should justify the exact number of study subjects (patients) to be involved in a study about the statistical power calculation.
When determining the duration of a study, a sponsor should consider the way the device is intended to be used, and also the specific conditions or disease to be addressed by the device in question. In this respect, the authority mentions that duration should always be justified, taking into account the timeframe of expected complications. The authority states that since cardiovascular devices have a long expected in vivo life, such devices should remain compliant with the applicable safety- and performance-related requirements within the whole expected lifetime.
Clinical Evaluation Report
As further explained by the TGA, a party responsible for a clinical trial should compile a clinical evaluation report (CER). According to the guidance, in compiling the clinical evidence the manufacturer should ensure that a clinical excerpt in the relent field critically evaluates all the clinical data from the clinical investigation(s), literature review, and/or post-market data (clinical experience) and endorses the CER (evidenced by signature and date), to demonstrate that the clinical evidence is sufficient to comply with the applicable EPs and that the device is safe and performs as intended. Recommendations provided in the present guidance should be taken into consideration by medical device manufacturers irrespective of whether direct or indirect clinical evidence is used.
By the applicable requirements, a clinical evaluation report should contain the following elements:
- General details;
- Description of the medical device and its intended application;
- Intended therapeutic and/or diagnostic indications and claims;
- Context of the evaluation and choice of clinical data types;
- Summary of relevant preclinical data;
- Discussion regarding comparable devices including substantially equivalent devices;
- Summary of the clinical data and appraisal;
- Data analysis;
- Name, signature, and curriculum vitae of clinical expert and date of the report.
Apart from the elements outlined herein above, the authority also expects medical device manufacturers to provide:
- Documentation related to risk assessment;
- Samples of the instructions for use, labeling, manuals, and other documentation accompanying the product (it is important to ensure the documents reflect information about the risks associated with the use of the device).
Depending on the nature of the device in question and specific characteristics and features thereof, the manufacturer should also submit additional specifications, details about the materials used, other products that could be used together with the device, the results of biocompatibility testing or animal studies, as well as of any other testing.
In summary, the present TGA guidance highlights the key points related to the clinical evidence for cardiovascular devices. The document explained the approach to be applied when collecting clinical evidence and submitting it to the authority to demonstrate compliance with the applicable requirements in terms of quality, safety, and effectiveness.
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