What are the requirements for power injection in intravascular contrast catheters?
1) For contrast catheter products injected using a high-pressure injection device, the maximum burst pressure information must be marked in the technical requirements and instructions (label), and the requirements for power injection should be specified in accordance with YY0285.1-2017. 2) For contrast catheter products injected using a loop handle syringe, there is no need to establish power injection requirements. The following warning should be clearly stated in the instructions: Do not use a high-pressure injection device to inject contrast agents. For other catheters that include vascular imaging functionality, refer to the above requirements.
What should be done if the instructions for in vitro diagnostic devices change?
According to Article 16 of the "Regulations on the Management of Instructions and Labels for Medical Devices" (Order No. 6): "When a registered medical device undergoes a registration change, the applicant must modify the instructions and labels according to the change document after obtaining it. If there are other changes in the instructions, the applicant must inform the medical device registration approval department in writing and submit relevant documents such as a comparison explanation of the changes to the instructions."
What are the focus points regarding the product instructions in the clinical trials of in vitro diagnostic reagents?
During the design and execution of clinical trials for in vitro diagnostic reagents, special attention should be paid to the consistency between the operational details in the clinical trial process and the related product instructions. This includes the instructions for the in vitro diagnostic reagents used in the trial, comparative reagents, and review reagents. For both the trial-specific in vitro diagnostic reagents and the comparative and review reagents used, the aspects of the instructions that should be particularly focused on in clinical trials include the intended use, applicable sample types, sample anticoagulants, sample preservation and handling requirements, sample processing reagents (such as nucleic acid extraction reagents) and other supporting reagents, applicable machine types, test methods, criteria for interpreting results, limitations, etc. During the clinical trial design process, detailed standard operating procedures should be established according to the relevant instructions to ensure that the testing of comparative and review reagents during the clinical trial is conducted strictly in accordance with the instructions. The clinical trial testing process and results for the trial-use in vitro diagnostic reagents should support the claims made in the product instructions of the product intended for registration.
Orthopedic metal implants undergo an anodizing process, which can be performed by the applicant themselves or outsourced to a third party. The documentation submitted differs depending on the approach.
If the anodizing is conducted by the applicant, they must submit their own anodizing process documentation, including cytotoxicity, surface element qualitative analysis, and process validation data. If the anodizing is outsourced to a third party, in addition to providing the third party's recognized anodizing process documentation, the applicant must also submit documents reviewing the third party's anodizing process, including quality control requirements and the basis for these requirements.
If a declared product exchanges video data with a compatible product via a non-wired method, should network security be considered?
Referencing the "Guidelines for Technical Review of Medical Device Cybersecurity," electronic data exchange methods include wireless and wired networks, unidirectional and bidirectional data transmission, and real-time and non-real-time remote control and storage media. Exchanging video data through a non-wired method falls under electronic data exchange and should adhere to the corresponding network security requirements.
Do clinical trials need to use all model specifications of the declared product?
It is recommended to analyze the differences between each model of the declared product based on its intended use, the objectives of the clinical trial, and evaluation indicators. Combine these findings with the results of the declared product's model specifications to comprehensively assess whether the model specifications used in the clinical trials can represent all model specifications of the declared product.
How is the effective period of a software product determined?
The usage period of standalone software is determined by commercial factors. The lifespan of software components is the same as that of the medical devices they are part of, and does not need to be separately indicated. The lifespan requirements for specialized standalone software are considered the same as those for standalone software and are reflected in the lifespan research materials of the medical devices they belong to.
Why Disposable Ligation Clips Require Animal Testing
Disposable ligation clips need to deliver the right amount of closure force when clamping tissue. If the force is too low, it's not effective for stopping bleeding, and if it's too high, it can cause ischemic necrosis at the tissue ends of the closure, hindering wound healing. Bench tests usually use latex, silicone tubes, or ex vivo tissues/vessels instead of human blood vessels. However, these cannot fully simulate the conditions of blood vessels during and after surgery, such as the structure of the vessel walls, and postoperative pathophysiological states like inflammation, edema, and fibrosis. Therefore, they can't adequately assess the product's effectiveness and safety, making animal testing necessary.
What should be considered for calibration and quality control of comparison reagents in the clinical evaluation of in vitro diagnostic reagents?
In vitro diagnostic reagents that are exempt from clinical trials should include calibration and quality control materials in the selected comparison reagent composition during clinical evaluation, or the approval documentation for the comparison reagents should explicitly specify the corresponding calibration and quality control materials. During the experimental operations, it is crucial to strictly follow the instructions of the comparison reagents for calibration and quality control to ensure the reliability of the test results.
For orthopedic metal implants, for products with different anodic oxidation surface treatments, what should be considered for the typical model/worst-case scenario in performance research data and test reports?
For orthopedic metal implants, colored anodized products and non-colored products can be interchangeable, and a typical model/worst-case scenario can be selected for testing/performance studies. Non-colored/colored anodized products and micro-arc oxidized products are not interchangeable, and typical models/worst-case scenarios should be selected separately for testing/performance studies.