How should the registration unit for sternal plates be divided?
Sternal plates are used for sternal fixation after sternotomy or internal fixation of sternal fractures. If the constituent materials (including material grades) of the product are different, they should be classified into different registration units. If the constituent materials of the product components are different but are used as a whole assembly or in combination, they can be declared under the same registration unit. Accessories such as bone screws used in conjunction with sternal plates can be registered together with the sternal plate to form a sternal fixation system.
How to determine the sample size in clinical trials of medical devices
The sample size for a trial is determined based on the main evaluation criteria of the trial. The clinical trial protocol should outline the relevant factors for determining the sample size and the specific calculation method for the sample size. Relevant factors for determining the sample size include the type of clinical trial design and comparison, the type and definition of the main evaluation criteria, the clinically meaningful threshold δ for the main evaluation criteria (if applicable), relevant parameters for the main evaluation criteria (such as expected efficacy rate, mean, standard deviation, etc.), Type I error rate α and Type II error rate β, as well as the expected dropout rate of subjects. The relevant parameters for the main evaluation criteria are estimated based on publicly available data or the results of exploratory trials. The clinical trial protocol should clearly specify the basis for these estimated values. For example, in the design of a non-inferiority trial for an aortic stent graft, it is generally recommended to set α at two-sided 0.05 and β not exceeding 0.20. You can refer to the "Guiding Principles for the Design of Clinical Trials of Medical Devices" for more details. For medical devices with specific sample size requirements outlined in the relevant guidance principles, it is important to consider meeting the corresponding requirements as per the guidance principles.
There are various products on the market containing sodium hyaluronate, such as eye drops, face masks, and intra-articular injection solutions. Which of these products are considered medical devices?
According to the "Announcement on the Management Categories of Medical Sodium Hyaluronate Products" (CFDA Announcement No. 81 of 2009), medical sodium hyaluronate (hyaluronic acid sodium) products are categorized based on different clinical uses (indications) as follows: (1) Products with a defined pharmacological effect used to treat arthritis, dry eye syndrome, skin ulcers, etc., are managed as pharmaceuticals. (2) Products used for assisting ophthalmic surgery, preventing surgical adhesions, filling to increase tissue volume, etc., are managed as medical devices. Injectable modified sodium hyaluronate used in plastic surgery, intended to increase tissue volume, should be managed as Class III medical devices. For injectable cosmetic products used in plastic surgery that are not intended to increase tissue volume, their classification as medical devices depends on their specific ingredients and primary mechanisms of action. Companies must apply to the relevant authorities for the determination of the product's management category or attributes before declaring them.
Requirements for environmental testing of in vitro diagnostic equipment
In vitro diagnostic equipment generally specifies its environmental conditions in the instructions or labels. Therefore, whether it's a domestic or imported product, when there are changes in the environmental conditions of in vitro diagnostic equipment applying for product registration or approved products, the relevant verification data for environmental testing must be submitted to demonstrate the safety and effectiveness of the declared product under its claimed environmental conditions. 1. If the declared product complies with applicable mandatory standards that reference GB/T 14710, environmental testing should be included as part of the product's technical requirements. Refer to the requirements of the mandatory standards without needing to detail each experimental condition; simply state that it should comply with the applicable chapters of GB/T 14710. The registration inspection report should include the content of the environmental testing. 2. If the declared product doesn't comply with applicable mandatory standards, one of the following documents can be submitted as verification data demonstrating that environmental conditions do not affect the safety and effectiveness of the product, and there is no need to reference GB/T 14710 in the product's technical requirements: (1) Registration inspection report including environmental testing. (2) Commissioned inspection report for environmental testing. (3) Research data showing that environmental conditions do not affect the safety and effectiveness of the product, including climate conditions (temperature, humidity), mechanical conditions (vibration, impact), transportation conditions, power adaptability, and other relevant factors.
If the registered product includes two models A and B, can the applicant choose the typical model A to conduct clinical trials?
It is possible to select the typical model A for clinical trials. For model B, which has not undergone clinical trials, the similarities and differences between model B and model A should be detailed, evaluating whether the differences adversely affect the safety and effectiveness of the product.
Can the principles of sample size calculation in the design of clinical trials of clinical testing instruments refer to the "Guidelines for the Design of Clinical Trials of Medical Devices"?
Yes, they can. The "Guidelines for the Design of Clinical Trials of Medical Devices" clearly state that these guidelines apply to medical devices with established product composition, design, and performance, including therapeutic and diagnostic products, but not in vitro diagnostic reagents. Therefore, when calculating sample size in the design of clinical trials of clinical testing instruments, the relevant requirements of these guidelines can be referenced.
In clinical trials of in vitro diagnostic reagents, if nucleic acid sequence determination, GC-MS/MS, and other laboratory detection reference methods are used as comparative methods for comparative studies, can testing be outsourced?
For some in vitro diagnostic reagents that currently lack a clear clinical diagnostic "gold standard" and have no comparable similar products on the market, clinical trial researchers should establish reasonable methods for comparative studies based on existing clinical practices and theoretical foundations. For some in vitro diagnostic reagents, in clinical trials, nucleic acid sequence determination, GC-MS/MS, and other laboratory detection reference methods are used as comparative methods for comparative studies. These methods are not routine clinical detection techniques, requiring specialized equipment and testing conditions, which clinical trial institutions may not have. In such cases, applicants should select clinical trial institutions with the necessary conditions as much as possible to conduct clinical trials. For clinical trial institutions without testing conditions, some testing can be outsourced to specialized sequencing institutions or laboratories with certain testing qualifications, and the test results should be recognized. Submit the delegation certificates between the clinical trial institution and the commissioned institution and evaluate the methodological research and overall quality of the comparative methods.
When conducting clinical trials for peripheral vascular stent products, what are the main endpoint suggestions?
For peripheral vascular stent products, the main recommended endpoint for current clinical trials is generally the target vessel patency rate at 12 months.
How should the registration units of suture anchor nail products be divided?
Suture anchor nails are used for fixation between bone and soft tissue, consisting of sutures and anchor nails. If the composition materials of the anchor nails (including material specifications) are different, they should be divided into different registration units. Similarly, if the composition materials of the sutures used in conjunction are different, they should also be divided into different registration units. If the declared product is composed of multiple sutures or if one suture is made from multiple materials but is used as a whole assembly or in combination, it can be declared under the same registration unit.
When submitting clinical ethics documents in the registration application for in vitro diagnostic reagents, what should be noted?
During the registration application for in vitro diagnostic reagents, clinical trials must comply with the ethical guidelines of the Helsinki Declaration and must obtain approval from the ethics committee of the clinical trial institution. In this section of the application materials, the review opinions of the ethics committee and a sample of the informed consent form for subjects should be submitted. The written approval from the ethics committee to conduct clinical trials should be submitted in its original form, stamped by the ethics committee, and should clearly state the version number and date of the protocol. Attention should be paid to ensuring the consistency of product information and clinical trial information with actual clinical conditions. If there are any protocol modifications during the trial, they should be approved by the ethics committee, and the committee's opinions on the protocol modifications should be submitted. All institutions conducting clinical trials should submit the review opinions of the ethics committee. If special medical institutions (such as disease control centers, etc.) do not have an ethics committee, the institution should provide relevant explanations and opinions on ethical aspects. If, after review and approval by the ethics committee, the clinical trial is exempt from obtaining informed consent from subjects, this exemption should be clearly stated in the written opinion of the ethics committee to avoid situations where the actual trial is exempt from informed consent, while the informed consent form is still mentioned in the ethics committee's written opinion.