Clinical evaluation of spinal fusion devices has technical review guidelines issued by the Center for Medical Device Evaluation (CMDE) under the National Medical Products Administration (NMPA) on June 28, 2023.
This blog post provides an overview of the key requirements and considerations as highlighted in the guidelines for conducting clinical evaluations on spinal fusion devices of the same category (13-03-04) using titanium and titanium alloy materials, as well as polyether ether ketone (PEEK) polymers.
Scope of Application
The guidelines focus on the clinical evaluation of conventionally designed spinal fusion devices categorized as class III medical devices in the current medical device classification catalogue. It covers devices made from titanium and titanium alloys (TA2G, TA3G, TC4, TC20, TC4 ELI) or PEEK polymers, primarily used in spinal fusion surgeries, however, not including artificial vertebral bodies, devices with novel materials or designs, and custom-made spinal fusion devices.
Selecting Comparable Devices
When conducting clinical evaluations, applicants must choose one or more devices from the same category for comparison with their proposed product. The selected devices should have similar design features to the applicant’s device. The more dissimilar the design features, the greater the need for justifying the impact of these differences on the safety and effectiveness of the applicant’s device.
Comparing Scope and Clinical Information
Applicants must compare the scope and clinical use information of the devices under evaluation. This includes assessing the applicable spinal segments, indications, target patient populations, surgical approaches, contraindications, warnings, and precautions.
Analyzing Technological Differences
Detailed comparisons of the technological features between the applicant’s device and the selected devices are essential. This includes evaluating design and critical dimensions, material properties, and device performance. Mechanical testing, such as compression, shear, torsion, and settling tests, should be performed and the results presented in tabular form.
Applicants should demonstrate that their device is non-inferior to the selected devices in terms of safety and effectiveness. Differences between the applicant’s device and the selected devices that affect performance should be thoroughly analyzed and justified based on clinical data and risk-benefit considerations.
Collecting Clinical Data
The guidelines emphasize the importance of collecting clinical data, including clinical literature, adverse event reports, and clinical trial data, for the selected devices. The data should be organized systematically, including patient information, device details, study design, and outcome measures.
Read the original CMDE announcement on registration review guidelines for clinical evaluation of spinal fusion devices.
By adhering to the outlined requirements, manufacturers can ensure their products meet the necessary safety and performance standards. Also, Cisema can assist manufacturers in navigating the registration process effectively. Discover our services for medical device registration, renewals and NMPA Legal Agent.