Does the CO2 laser therapy device, with its new design structure for new clinical application sites, require animal testing? And is it necessary to have a control group in animal testing?
Animal testing primarily provides evidence to support the finalization of product design and serves as a basis for determining whether a medical device can enter the clinical research phase, thereby protecting clinical subjects. If the product employs a new mechanism of action, working principle, structural design, application method (e.g., surgical operation), or improves certain aspects of performance, the applicant should assess the risks related to the product's innovation points and verify and/or confirm the effectiveness of risk control measures, deciding whether to conduct animal testing based on the principles of risk management. If the proposed CO2 laser therapy device adopts a new structural design, improves performance, or introduces new functionalities (such as dot matrix scanning) for new clinical uses, and if bench performance testing is insufficient to determine its basic safety, it is recommended to conduct animal testing before clinical trials. Animal testing does not necessarily require a control group.
What issues should be considered in the registration documents for large imaging equipment that provides a third-party physiological gating signal interface but does not include the gating device?
For large imaging equipment (such as CT, MR, PET/CT, etc.) that provides a third-party physiological gating interface, such as a respiratory gating interface or an ECG gating interface, it should be clearly stated in the summary documents the requirements for third-party gating devices that can be used in conjunction, such as interface type (including connection methods, data protocols, etc.), compliance standards, etc. If it is a proprietary interface, the manufacturer and product model of compatible devices should also be specified. Research documents should provide verification and confirmation materials for tests conducted with third-party devices. The product technical requirements should specify the interface type (including connection methods, data protocols, etc.) and compliance standards (if applicable), and technical indicators related to gating should be tested.
What issues should be considered in the registration documents for large imaging equipment that provides a third-party physiological gating signal interface but does not include the gating device?
For large imaging equipment (such as CT, MR, PET/CT, etc.) that provides a third-party physiological gating interface, such as a respiratory gating interface or an ECG gating interface, it should be clearly stated in the summary documents the requirements for third-party gating devices that can be used in conjunction, such as interface type (including connection methods, data protocols, etc.), compliance standards, etc. If it is a proprietary interface, the manufacturer and product model of compatible devices should also be specified. Research documents should provide verification and confirmation materials for tests conducted with third-party devices. The product technical requirements should specify the interface type (including connection methods, data protocols, etc.) and compliance standards (if applicable), and technical indicators related to gating should be tested.
When changing the center thickness of soft contact lenses, should the impact on oxygen permeability be considered?
The inspection indicators for a product's oxygen permeability mainly include the oxygen permeability coefficient and the amount of oxygen transmitted. The oxygen permeability coefficient is related to the lens material formula and not to the lens thickness. However, the amount of oxygen transmitted is directly related to the lens thickness. When changing the product's center thickness, it is necessary to consider performing a risk analysis on how changes in lens thickness affect the amount of oxygen transmitted and, if necessary, provide corresponding validation data. Attention should be paid to whether the nominal value of the amount of oxygen transmitted needs to be modified. If a modification is indeed necessary, the corresponding test reports should be submitted as supporting documents, along with the rationale for setting the oxygen transmission indicators.
How to choose a typical model for inspection among the various specifications and models of medical endoscopes?
Generally, the selection of a typical model for testing within the same registration unit of medical endoscopes should consider the following factors: if there is a difference in the direction of view, the maximum value should be chosen; if there is a difference in the field of view, both the maximum and minimum values should be chosen; for endoscopes with different inner diameters, outer diameters, and working lengths, the one with the smallest diameter and the highest aspect ratio (length/diameter) should be chosen. For products with a working channel, the diameter should be the outer diameter of the insertion part minus the inner diameter of the working channel; for optical performance indicators like angular resolution, the model with the highest requirements should be chosen.
How should the suppliers of the main raw materials be filled out in the appendix of the technical requirements for in vitro diagnostic reagent products?
The appendix of the technical requirements for in vitro diagnostic reagent products requires the source of the main raw materials to be marked. If purchased externally, the supplier should be specified. Here, the supplier should be the producer of the raw materials, not a distributor or agent. Accordingly, a change in the suppliers of the main raw materials in the case of registration changes refers to a situation where the producer of the raw materials has changed.
How should the registration units for dental composite resin products be classified?
Dental composite resin materials typically refer to three-dimensional compounds composed of at least two different chemical substances with a clear interface separation, mainly including the resin matrix, surface-treated inorganic or organic fillers, and initiator systems, as well as containing other components like inhibitors and pigments, used for direct filling restorations or base linings for dental defects. Products with different curing mechanisms (such as light curing, chemical curing) should be classified into different registration units; products with different main chemical components in the resin matrix should be classified into different registration units; products whose key performance indicators (such as wear resistance, polymerization shrinkage) and expected clinical use or purpose change due to changes in the chemical components of the reaction system should be classified into different registration units; products with different clinical application techniques should be classified into different registration units. Products that only differ in color can be declared as a single registration unit.
Can the potential risk of pyrogenic reactions in infusion products be determined by bacterial endotoxin indicators?
Pyrogenic reactions are among the most severe adverse reactions when using infusion products clinically. Pyrogens include bacterial pyrogens, endogenous high-molecular pyrogens, endogenous low-molecular pyrogens, and chemical pyrogens, with endotoxin tests targeting bacterial endotoxins produced by Gram-negative bacteria. 1) Pyrogens cannot be eliminated by sterilization methods; 2) Other pyrogenic substances besides endotoxins can also cause pyrogenic reactions. Therefore, the potential risk of pyrogenic reactions cannot be solely determined by testing the limits of endotoxins. It requires reducing this risk through manufacturing processes and process controls.
How should the primary endpoints for clinical trials of peripheral drug-coated balloon catheters be chosen?
Currently, it is recommended that the primary research endpoints for clinical trials of peripheral drug-coated balloon catheters include both primary efficacy endpoints and primary safety endpoints. For primary efficacy endpoints, a composite endpoint is recommended, which includes the rate of clinically driven target lesion revascularization and the rate of restenosis diagnosed by Doppler ultrasound at 12 months post-operation. Similarly, for primary safety endpoints, a composite endpoint is recommended, including all-cause mortality at 30 days, as well as the amputation rate of the lesion limb and the rate of clinically driven target vessel revascularization (TVR) at 12 months post-operation.
For products that are already registered, can you apply for a change in the license to add a model? Can you apply for a license change to add accessories?
The content within the same registration certificate should meet the requirements of the "Guidelines for the Division of Medical Device Registration Units." Whether it's possible to add new models or accessories to the original registered product depends on the differences between the new and existing models, and the relevance of the new accessories to the original product. If the new models or accessories can be classified into the same registration unit as the already registered product according to the "Guidelines for the Division of Medical Device Registration Units," then it's possible to apply for an addition through a change in the license items.