The new article describes in detail the approach to be applied for clinical evidence for joint prostheses.
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 medical devices. The document highlights the key points to be considered for device-specific requirements for clinical evidence to be provided by medical device manufacturers when applying for marketing approval for different types of products intended to be marketed and used in Australia. The scope of the guidance covers, inter alia, the aspects related to total and partial joint prostheses.
It is important to mention that the present guidance document is non-binding in its legal nature, and is not intended to introduce new rules or impose new obligations, but rather to provide additional clarifications regarding the applicable regulatory requirements, as well as recommendations to be taken into consideration to ensure compliance thereto. The authority also reserves the right to make changes to the guidance, should it be reasonably necessary to reflect the respective amendments to the underlying regulations.
According to the guidance, joint replacement (also referred to as arthroplasty) stands for a commonly performed orthopedic operation to relieve pain and improve mobility; while the joint prostheses described in the guidance include devices used in the hip, knee, shoulder, ankle, elbow, and wrist joint replacements.
The document provides an overview of the approach to be applied for clinical evidence for the said devices the medical device manufacturer should submit to the authority to demonstrate that the device in question meets any regulatory requirements in terms of safety and effectiveness it is subject to. This includes, inter alia, a demonstration of compliance with the applicable Essential Principles (EPs) of safety and performance as set forth by Medical Devices Regulations. In this respect, the authority additionally emphasizes that the scope of the present guidance covers any joint prostheses including, inter alia, joint replacement medical devices.
Recommendations: Key Points
The guidance further provides a summary of recommendations to be taken into consideration by medical device manufacturers and other parties involved when applying for marketing approval for joint prostheses. According to the document, medical device manufacturers should provide information about possible combinations of the products they are responsible for, and then submit clinical data demonstrating compliance with the applicable safety and performance requirements for all of the combinations. The authority additionally emphasizes the importance of rigorous assessments such devices should be subject to since these devices need to have a long in vivo life without exposing the patient to unduly high risks of adverse events or undesirable effects.
The main recommendations provided by the TGA include, inter alia, the following ones:
- Clinical data is in the form of DIRECT evidence (about the subject device/system only) or INDIRECT evidence (data on a substantially equivalent device/system).
- In case the information provided is based on the assessment of data initially related to a similar medical device, such information should be accompanied by a proper justification confirming that both devices are deemed to be substantially equivalent, while the differences existing between them are not sufficient enough to impact adversely the safety and performance of the device subject to review.
- The applicants should also provide information regarding the clinical context within which the clinical data were obtained; the clinical context of the data should be congruent with the indications for use.
- For the way clinical data should be provided, the authority emphasizes the following:
- When deciding on the design of a clinical study, a responsible party should take into consideration the way the device is intended to be used, as well as the risks associated thereto;
- The post-trial patient follow-up should last at least 2 subsequent years upon completion of a study;
- When deciding on the study endpoints, a responsible party should take into account similar (in terms of intended use, class, and patient population) medical devices.
- Special attention should be paid to the risks related to the delayed need for revision surgery (due to the expected long-term use of the devices covered by the scope of the guidance, the period to be considered should be more than two years).
The guidance also provides recommendations for comprehensive literature reviews, as well as the compilation and presentation of clinical evidence.
Main Concepts and Definitions
As further explained by the TGA, a joint prosthesis stands for an implantable medical device, irrespective of its configuration, that is intended by the manufacturer to replace in full or in part a section of the joint. According to the guidance, in terms of design, such devices could be monoblock or modular. The authority mentions that the modular ones provide additional flexibility to meet better the needs of a specific patient. At the same time, such products are usually more complex, and the benefit-risk profile for them would be different as well, so these matters should be assessed on a case-by-case basis.
The scope of the present guidance also covers limb-preserving devices – the ones that are designed for functional limb reconstructions for patients with significant bone loss usually around the knee and hip.
In summary, the present guidance provides an overview of the regulatory policy the authority applies for total and partial joint prostheses. The document highlights the key points to be taken into consideration when determining the scope of clinical evidence to be submitted when applying for marketing approval for such devices and also outlines specific features associated thereto.
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