What factors should be considered when determining the service life of active medical devices? What documentation should be submitted?
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.
Common Questions About Clinical Trial Enrollment Case Samples for In Vitro Diagnostic Reagents-Requirements for Case Enrollment
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.
Common Questions About Clinical Trial Enrollment Case Samples for In Vitro Diagnostic Reagents-Sample Number Requirements for Multiplex Testing Products
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.
Common Questions About Clinical Trial Enrollment Case Samples for In Vitro Diagnostic Reagents-Requirements for the Total Number of Samples
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.
Common Questions About Clinical Trial Enrollment Case Samples for In Vitro Diagnostic Reagents-Clinical Exemptions for In Vitro Diagnostic Reagents Used for Rare Disease Detection
For in vitro diagnostic reagent products used for rare disease detection, the number of clinical positive samples can be appropriately reduced, but the total number of clinical positive samples should be statistically significant.
Common Questions About Clinical Trial Enrollment Case Samples for In Vitro Diagnostic Reagents-Sample Number Requirements for Multi-Locus Gene Mutation Detection Products
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.
Common Questions About Clinical Trial Enrollment Case Samples for In Vitro Diagnostic Reagents-Requirements for Clinical Sample Types
The sample type should be consistent with what is claimed in the instructions. For situations covering different sample types, if the product's claimed different sample types are comparable, such as serum or plasma, one type of sample should be primarily used. The sample quantity should meet the "Technical Guidelines for Clinical Trials of In Vitro Diagnostic Reagents" for clinical trials, with additional clinical trials comparing other types of samples to the aforementioned samples. The number of comparison samples should meet the requirement of at least 200 cases for Class III products and at least 100 cases for Class II products, conducted in at least two (including two) clinical trial institutions. If different sample types are not comparable, one type of sample volume should meet the "Technical Guidelines for Clinical Trials of In Vitro Diagnostic Reagents," with the remaining sample types compared to the control reagent, increasing each sample type as appropriate compared to the aforementioned situation.
Factors to Consider in the In Vitro Degradation Test of Absorbable Hemostatic Products
When conducting in vitro degradation studies on absorbable hemostatic products, it is recommended to simulate in vivo conditions (such as the environment at 37°C, proteolysis, etc.) to study the time required for the product to be completely absorbed and degraded, as well as all degradation products. It is advisable to establish reasonable in vitro degradation study methods based on the product characteristics and clinical applications. It is recommended to refer to existing standard methods and compare them with similar products that are already on the market. The suggested observation indicators for in vitro degradation studies include product solubility, degradation cycle, conditions required for degradation, the relationship between degradation speed and conditions, the main degradation products and their quantities, and morphological changes (disintegration process, whether there are fragments falling off, fragment swelling, etc.).
How to analyze clinical trial data for quantitative detection products of in vitro diagnostic reagents
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.
What clinical sites should be considered during clinical trials for Class III X-ray products?
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.