TX Q&A

For products that detect multi-locus gene mutations, the total number of clinical samples should comply with the "Technical Guidelines for Clinical Trials of In Vitro Diagnostic Reagents." The number of positive and negative samples for each mutation type should be statistically significant, fully verifying the clinical performance of each mutation type detection. For clinically rare mutation types, the number of positive samples in clinical samples can be reduced as appropriate, but a sufficient number of cases should be ensured for comprehensive clinical performance validation.

For multiplex testing products, such as multi-drug testing reagents, the clinical samples should meet the total sample number requirements for each analyte as per the "Technical Guidelines for Clinical Trials of In Vitro Diagnostic Reagents," with a reasonable sample distribution to statistically analyze and verify their clinical performance.

The total number of clinical samples should meet the basic requirements of the "Technical Guidelines for Clinical Trials of In Vitro Diagnostic Reagents." The distribution of positive samples, negative samples, and interference samples should meet the statistical requirements of individual clinical institutions and overall statistics, sufficiently verifying the product's clinical performance and effectively validating the product's intended use.

Clinical samples in clinical trials refer to cases enrolled according to the clinical trial protocol. All enrolled cases should be unique and traceable, covering the product's intended use and potential interference factors, taking into account the indications claimed during the product's clinical use and possible interference factors. Clinical samples should use prospective samples as much as possible, though some retrospective samples may be used if necessary. However, it should still be possible to trace these cases, and it's recommended to explain the use of retrospective samples in the clinical trial protocol.

According to Article 16 of the "Regulations on the Supervision and Management of Medical Devices": For newly developed medical devices not yet included in the classification catalog, applicants can directly apply for product registration in accordance with the provisions of this regulation on the registration of Class III medical device products. Alternatively, they can determine the product category based on the classification rules and apply to the State Food and Drug Administration department for category confirmation, and then apply for registration or product filing in accordance with the provisions of this regulation.

1. The determination of the service life of active medical devices can consider the following aspects: the service life of critical components such as highly reliable components, normal operation and single fault state during use, usage frequency, operating environment (corrosion, wear, radiation, etc.), cleaning/disinfection/sterilization methods, maintenance of components, and preliminary experience data, etc. 2. Applicants should submit the basis for determining the expected service life of the product and verification reports. The verification report can provide the service life verification content of the system/equipment, or the service life verification content of critical components, or experience data, etc. 3. Relevant parties (manufacturers/users) should dynamically evaluate the service life of the product through risk analysis throughout the product's entire life cycle. When the safety is reduced to an unacceptable level of risk, the use should be discontinued.

When abnormal results are found in chemical performance studies, it is recommended that the applicant assess the reasons for the anomaly and evaluate the safety of the medical device comprehensively. For example, for catheter products with a coating, if the coating material causes abnormal results in the reducing substances test, it is suggested to test products without the coating to confirm if their chemical performance is acceptable. At the same time, consider the clinical application history of the coating material and biocompatibility data for a comprehensive evaluation.

Refer to the "Technical Review Guidelines for the Registration of Medical X-ray Diagnostic Equipment (Class III) Products." Clinical sites include the chest, abdomen, bones and soft tissues; if used for contrast examinations, sites should also include the gastrointestinal tract, aorta, organ and organ vessels, coronary arteries (if any). The clinical sites vary with the product.

For quantitative detection products, the clinical trial results should use appropriate statistical analysis methods like regression analysis, based on the detection performance of the product. Within a reasonable confidence interval, it should be examined whether there is significant correlation between the results of the two reagents and whether there are significant statistical differences in the quantitative results. If possible, it's recommended to consider the potential performance differences of the reagents at different sample concentration intervals, perform interval stratification statistics for the overall concentration range, and conduct correlation analysis for results within different concentration intervals to better verify the correlation between the two reagents.

Applicants should submit technical or evidential documentation that effectively proves or elucidates the hemostatic action principle of the declared product. Applicants should elaborate in detail on the hemostatic mechanism of the product, describe how the product affects the hemostasis process, the product's advantageous role during hemostasis, and confirm whether the combination of this hemostatic mechanism with the declared product application is scientifically reasonable. Review domestic and international research literature supporting this hemostatic principle and submit the original scientific literature and its Chinese translation that specifically support this hemostatic principle. Clarify whether there are already products applying the same hemostatic principle on the market domestically and abroad, and research whether the declared product might cause adverse reactions related to its use, such as thrombosis formation, coagulation disorders, etc.